Abbott XIENCE Sierra Page 6 Manual Download

Page: 6 / 206

•

Pneumonia

•

Pyrexia

•

Rash

•

Renal failure

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Upper respiratory tract infection

•

Urinary tract infection

•

Venous thromboembolism

•

Vomiting

•

Wound healing complications (including wound infections and lymphocele)

8.0 PATIENT SELECTION AND TREATMENT
8.1 Individualization of Treatment

The risks and benefits described above should be considered for each patient before using

a device from the family of XIENCE EECSS. Patient selection factors to be assessed should

include judgment regarding risk of antiplatelet therapy. Special consideration should be given

to those patients with recently active gastritis or peptic ulcer disease.

Antiplatelet drugs should be used in combination with the XIENCE EECSS, per the guidelines

from the American College of Cardiology, American Heart Association, and Society for

Cardiovascular Angiography and Interventions (ACC/AHA/SCAI) and ESC guidelines.

Physicians should use the information from the large body of clinical evidence for XIENCE

stents, coupled with the current literature on drug-eluting stents, current guidelines and the

specific needs of individual patients, to determine the specific antiplatelet / anticoagulation

regimen to be used for their patients in general practice.

Current guidelines for the DAPT discontinuation should be followed and are recommended.

The decision to interrupt or discontinue DAPT is the responsibility of the treating physician,

taking into consideration the individual patient’s condition. In case an unanticipated

interruption or discontinuation of DAPT is required any time after one month following

XIENCE coronary stent implantation, two-year data from the XIENCE coronary clinical trials

show low stent thrombosis rates and no observed increased risk for stent thrombosis.

It is very important that the patient comply with the post-procedural antiplatelet

recommendations. Premature discontinuation of prescribed antiplatelet medication could

result in a higher risk of thrombosis, myocardial infarction, or death. Prior to percutaneous

coronary intervention (PCI), if a surgical or dental procedure is anticipated that requires

early discontinuation of antiplatelet therapy, the interventionalist and patient should carefully

consider whether a drug-eluting stent and its associated recommended antiplatelet therapy

is the appropriate PCI choice. Following PCI, should a surgical or dental procedure be

recommended, the risks and benefits of the procedure should be weighed against the

possible risk associated with premature discontinuation of antiplatelet therapy.
Patients who require premature discontinuation of antiplatelet therapy secondary to

significant active bleeding, should be monitored carefully for cardiac events and, once

stabilized, have their antiplatelet therapy restarted as soon as possible per the discretion of

their treating physicians.

9.0 CLINICIAN USE INFORMATION

9.1 Inspection Prior to Use

1. Carefully inspect the sterile package before opening and check for damage to

the sterile barrier. Do not use if the integrity of the sterile package has been

compromised.

2. Do not use after the “Use by” date.

3. Tear open the foil pouch and remove the inner pouch.

Note:

The outside of the inner pouch is NOT sterile. Open the inner pouch and pass or

drop the product into the sterile field using an aseptic technique.

4. Prior to using the XIENCE Sierra EECSS, carefully remove the system from the

package and inspect for bends, kinks, and other damage. Verify that the stent does

not extend beyond the radiopaque balloon markers. Do not use if any defects are

noted. However, do not manipulate, touch, or handle the stent, which may cause

coating damage, contamination, or stent dislodgement from the delivery balloon.

Note:

At any time during use of the XIENCE Sierra EECSS, if the stainless steel proximal

shaft has been bent or kinked, do not continue to use the catheter.

9.2 Materials Required

•

Appropriate arterial sheath

•

Appropriate guiding catheter(s)

•

2 – 3 syringes (10 – 20 cc)

•

1,000 u/500 cc heparinized normal saline (HepNS)

•

Rotating hemostatic valve with appropriate minimum inner diameter (0.096 inch

[2.44 mm])

•

0.014 inch (0.36 mm) x 175 cm (minimum length) guide wire

•

Guide wire introducer

•

Contrast diluted 1:1 with heparinized normal saline

•

Inflation device

•

Appropriate sized pre-dilatation angioplasty balloon

•

Appropriate sized post-dilatation noncompliant angioplasty balloon

•

Three-way stopcock

•

Torque device

•

Appropriate anticoagulation and antiplatelet drugs

9.3 Preparation
9.3.1 Packaging Removal
Note: The foil pouch is not a sterile barrier.

The inner header bag (pouch) within the foil

pouch is the sterile barrier. Only the contents of the inner pouch should be considered

sterile. The outside surface of the inner pouch is NOT sterile.

1. Carefully remove the delivery system from its protective tubing for preparation of the

delivery system. When using a rapid exchange (RX) system, do not bend or kink the

hypotube during removal.

2. Remove the product mandrel and protective stent sheath by grasping the catheter

just proximal to the stent (at the proximal balloon bond site), and with the other

hand, grasp the stent protector and gently remove distally. If unusual resistance is

felt during product mandrel and stent sheath removal, do not use this product and

replace with another. Follow product returns procedure for the unused device.

9.3.2 Guide Wire Lumen Flush

1. Flush the guide wire lumen with HepNS until fluid exits the guide wire exit notch.

Note:

Avoid manipulation of the stent while flushing the guide wire lumen, as this may

disrupt the placement of the stent on the balloon.

9.3.3 Delivery System Preparation

1. Prepare an inflation device / syringe with diluted contrast medium.

2. Attach an inflation device / syringe to the stopcock; attach it to the inflation port

of the product. Do not bend the product hypotube when connecting to the inflation

device / syringe.

3. With the tip down, orient the delivery system vertically.

4. Open the stopcock to delivery system; pull negative for 30 seconds; release to

neutral for contrast fill.

5. Close the stopcock to the delivery system; purge the inflation device / syringe of

all air.

6. Repeat steps 3 through 5 until all air is expelled. If bubbles persist, do not use the

product.

7. If a syringe was used, attach a prepared inflation device to stopcock.

8. Open the stopcock to the delivery system.

9. Leave on neutral.

Note:

While introducing the delivery system into the vessel, do not induce negative pressure

on the delivery system. This may cause dislodgement of the stent from the balloon.

Note:

If air is seen in the shaft, repeat

Section 9.3.3 Delivery System Preparation

, steps 3

through 5, to prevent uneven stent expansion.

9.4 Delivery Procedure

1. Prepare the vascular access site according to standard practice.

2. The decision to pre-dilate the lesion with an appropriate sized balloon should be

based on patient and lesion characteristics.

If pre-dilatation is performed,

limit the

length of pre-dilation by the PTCA balloon to avoid creating a region of vessel injury

that is outside the boundaries of the XIENCE Sierra stent.

3. For long lesions, size the stent to the diameter of the most distal portion of the

vessel.

Note:

If choosing between two stent diameters for tight lesions, choose the smaller

diameter stent and inflate. See product label for compliance information.

4. Maintain neutral pressure on the inflation device attached to the delivery system.

Open the rotating hemostatic valve as wide as possible.

5. Backload the delivery system onto the proximal portion of the guide wire while

maintaining guide wire position across the target lesion.

6. Carefully advance the delivery system into the guiding catheter and over the guide

wire to the target lesion. When using a Rapid Exchange (RX) system, be sure to keep

the hypotube straight. Ensure guiding catheter stability before advancing the stent

system into the coronary artery.

Note:

If unusual resistance is felt before the stent exits the guiding catheter, do not force

passage. Resistance may indicate a problem and the use of excessive force may result in

stent damage or dislodgement. Maintain guide wire placement across the lesion and remove

the delivery system and guiding catheter as a single unit.

7. Advance the delivery system over the guide wire to the target lesion under direct

fluoroscopic visualization. Utilize the radiopaque balloon markers to position the stent

across the lesion. Perform angiography to confirm stent position. If the position of

the stent is not optimal, it should be carefully repositioned or removed (see

Section

9.6 Removal Procedure

). The balloon markers indicate both the stent edges and the

balloon shoulders. Expansion of the stent should not be undertaken if the stent is not

properly positioned in the target lesion.

Note:

If removal of a stent system is required prior to deployment, ensure that the guiding

catheter is coaxially positioned relative to the stent delivery system, and cautiously withdraw

the stent delivery system into the guiding catheter. Should unusual resistance be felt at any

time when withdrawing the stent towards the guide catheter, the stent delivery system and

the guiding catheter should be removed as a single unit. This should be done under direct

visualization with fluoroscopy.

8. Tighten the rotating hemostatic valve. The stent is now ready to be deployed.

9.5 Deployment Procedure

CAUTION: Refer to product label for in vitro stent inner diameter, nominal pressure,

and RBP.

1. Prior to deployment, reconfirm the correct position of the stent relative to the target

lesion using the radiopaque balloon markers.

2. Deploy the stent slowly by pressurizing the delivery system in 2 atm increments,

every 5 seconds, until stent is completely expanded. Fully expand the stent by

inflating to nominal pressure at a minimum. Accepted practice generally targets an

initial deployment pressure that would achieve a stent inner diameter ratio of about

1.1 times the reference vessel diameter (refer to product label for

in vitro

stent inner

diameter, nominal pressure, and RBP).

3. For long lesions, size the stent to the diameter of the most distal portion of the

vessel and expand stent to nominal pressure at minimum. Maintain pressure for

30 seconds. If necessary, the delivery system can be repressurized or further

pressurized to assure complete apposition of the stent to the artery wall.

4. Maintain pressure for 30 seconds for full expansion of the stent. Fluoroscopic

visualization during stent expansion should be used in order to properly judge the

optimum stent diameter as compared to the proximal and distal native coronary

artery diameters (reference vessel diameters). Optimal stent expansion and proper

apposition requires that the stent be in full contact with the arterial wall.

Note:

See

Section 9.6 Removal Procedure

for instruction on withdrawal of stent delivery

system.

5. If necessary, the delivery system can be repressurized or further pressurized to

assure complete apposition of the stent to the artery wall.

Note: Do not exceed the labeled rated burst pressure (RBP) of 16 atm (1621 kPa).

6. Fully cover the entire lesion and balloon-treated area (including dissections) with the

XIENCE Sierra stent, allowing for adequate stent coverage into healthy tissue proximal

and distal to the lesion.

7. Deflate the balloon by pulling negative on the inflation device for 30 seconds. Confirm

complete balloon deflation before attempting to move the delivery system. If unusual

resistance is felt during stent delivery system withdrawal, pay particular attention to

guiding catheter position.

Note:

See

Section 9.6 Removal Procedure

for instruction on withdrawal of stent delivery

system.

8. Confirm stent position and deployment using standard angiographic techniques.

For optimal results, the entire stenosed arterial segment should be covered by the

stent. Fluoroscopic visualization during stent expansion should be used in order to

properly judge the optimum expanded stent diameter as compared to the proximal

and distal coronary artery diameter(s). Optimal expansion requires that the stent be in

full contact with the artery wall. Stent wall contact should be verified through routine

angiography or intravascular ultrasound (IVUS).

9. If the deployed stent size is still inadequate with respect to reference vessel diameter,

a larger balloon may be used to further expand the stent. If the initial angiographic

appearance is suboptimal, the stent may be further expanded using a low profile,

high pressure, noncompliant balloon dilation catheter. If this is required, the stented

segment should be carefully recrossed with a prolapsed guide wire to avoid

disrupting the stent geometry. Deployed stents should not be left underdilated.

CAUTION: Do not dilate the stent beyond the following limits.

Nominal Stent Diameter

Dilation Limit

2.0 – 3.25 mm

3.75 mm

3.5 – 4.0 mm

5.50 mm

10. If more than one XIENCE Sierra stent is needed to cover the lesion and balloon-

treated area, it is suggested that, to avoid the potential for gap restenosis, the stents

be adequately overlapped. To ensure that there are no gaps between stents, the

balloon marker bands of the second XIENCE Sierra stent should be positioned inside

the deployed stent prior to expansion.

11. Reconfirm stent position and angiographic results. Repeat inflations until optimal

stent deployment is achieved.

9.6 Removal Procedure

Withdrawal of the stent delivery catheter from the deployed stent:

1. Deflate the balloon by pulling negative pressure on the inflation device. Larger and

longer balloons will take more time (up to 30 seconds) to deflate than smaller and

shorter balloons. Confirm balloon deflation under fluoroscopy and wait 10 to

15 seconds longer.

2. Position inflation device on “negative” or “neutral” pressure.

3. Stabilize guide catheter position just outside coronary ostium and anchor in place.

Maintain guide wire placement across stent segment.

4. Gently remove the stent delivery system with slow and steady pressure.

5. Tighten the rotating hemostatic valve.

If during withdrawal of the stent delivery catheter resistance is encountered, use the

following steps to improve balloon rewrap:

•

Re-inflate the balloon up to nominal pressure.

•

Repeat steps 1 through 5 above.

Post stent delivery system withdrawal; Stent deployment confirmation

1. Confirm stent position and deployment using standard angiographic techniques.

For optimal results, the entire stenosed arterial segment should be covered by the

stent. Fluoroscopic visualization during stent expansion should be used in order to

properly judge the optimum expanded stent diameter as compared to the proximal

and distal coronary artery diameter(s). Optimal expansion requires that the stent be in

full contact with the artery wall. Stent wall contact should be verified through routine

angiography or intravascular ultrasound (IVUS).

2. If more than one XIENCE Sierra stent is needed to cover the lesion and balloon-

treated area, it is suggested that, to avoid the potential for gap restenosis, the stents

be adequately overlapped.

3. To ensure that there are no gaps between stents, the balloon marker bands of the

second XIENCE Sierra stent should be positioned inside the deployed stent prior to

expansion.

4. Reconfirm stent position and angiographic results to assess stented area. Repeat

inflations until optimal stent deployment is achieved. If post-dilation is necessary,

ensure that the final stent diameter matches the reference vessel diameter. Ensure

that the stent wall is in contact with the artery wall.

9.7 Post-deployment Dilation of Stent Segments

1. All efforts should be taken to ensure that the stent is not under-dilated.

2. If the deployed stent size is still inadequate with respect to the vessel diameter, or

if full contact with the vessel wall is not achieved, a larger balloon may be used to

expand the stent further. The stent may be further expanded using a low profile, high

pressure, and noncompliant balloon catheter. If this is required, the stented segment

should be recrossed carefully with a prolapsed guide wire to avoid dislodging the

stent. The balloon should be centered within the stent and should not extend outside

of the stented region.

CAUTION: Do not dilate the stent beyond the following limits.

Nominal Stent Diameter

Dilation Limit

2.0 – 3.25 mm

3.75 mm

3.5 – 4.0 mm

5.50 mm

10.0 SPIRIT AND XIENCE FAMILY OF CLINICAL TRIALS

The XIENCE Sierra EECSS is based on the predicate devices XIENCE V EECSS,

XIENCE PRIME EECSS, XIENCE Xpedition EECSS, and XIENCE Alpine EECSS.

The XIENCE Sierra EECSS uses a similar stent platform, identical drug coating formulation,

identical drug primer, similar nominal total drug content, and the identical stent

contacting balloon materials as the XIENCE PRIME EECSS, XIENCE Xpedition EECSS, and

XIENCE Alpine EECSS.

The XIENCE Sierra EECSS differs from the XIENCE Alpine EECSS in the stent delivery

system. The XIENCE Sierra stent delivery system utilizes the same principle of operation and

materials as other Abbott Vascular RX stent systems and coronary dilatation catheters.

Compared to the XIENCE V EECSS and to the XIENCE PRIME EECSS, the XIENCE Sierra

EECSS has the same stent security specification, same stent placement on the balloon

between the balloon markers, a similar tip entry profile, and a similar taper length for

XIENCE Sierra stent sizes up to 28 mm in length. Based on the similar nature of the

XIENCE Sierra stent to the XIENCE PRIME and XIENCE V stents, performance of the

XIENCE Sierra EECSS can be predicted to be similar to the performance of XIENCE V

and XIENCE PRIME. Therefore, clinical trial data for XIENCE V and XIENCE PRIME are

summarized in this section.

EL2115538 (2017-1

1-03

)

Page 6 of 206

Printed on : 2017-11-03

Summary of Contents for XIENCE Sierra

Page 1: ...m rkning av medicinsk utrustning Grafische symbolen voor de etikettering van medische hulpmiddelen Grafiske symboler beregnet til m rkning af medicinske produkter Symbole graficzne do oznaczania sprz...

Page 2: ...mstillingsdato Graphical Symbols for Medical Device Labeling Grafische Symbole zur Beschriftung von Medizinprodukten Symboles graphiques pour l tiquetage des dispositifs m dicaux S mbolos gr ficos uti...

Page 3: ...nificada Anv nd inte produkten om f rpackningen r skadad Gebruik het product niet als de verpakking beschadigd is M ikke anvendes hvis pakningen er beskadiget Stent post dilatation limit Nachdilatatio...

Page 4: ...erolimus Eluting Coronary Stent System is contraindicated for use in Patients who cannot tolerate including allergy or hypersensitivity to procedural anticoagulation or the post procedural antiplatele...

Page 5: ...sible for everolimus systemic concentrations to approach immunosuppressive levels temporarily especially in patients who also have hepatic insufficiency or who are taking drugs that inhibit CYP3A4 or...

Page 6: ...the target lesion Note If removal of a stent system is required prior to deployment ensure that the guiding catheter is coaxially positioned relative to the stent delivery system and cautiously withd...

Page 7: ...days None None None None Clinical Follow up 30 180 240 270 days 1 to 5 years 30 180 270 days 1 to 3 years 30 days 240 days 1 to 3 years 30 180 days 1 to 3 years 30 180 days 1 to 3 years Angiographic...

Page 8: ...e treatment of patients with de novo coronary artery lesions XIENCE V India is a prospective open label multi center observational single arm registry to evaluate XIENCE V EECSS s continued safety and...

Page 9: ...lysis of the following pre and post market trials Pre market SPIRIT II SPIRIT III SPIRIT IV Post market SPIRIT V SPIRIT Women XIENCE V USA XIENCE V India Table 10 3 1 Stent Thrombosis ARC Definite Pro...

Page 10: ...ei L sionen der Koronararterie chronisch vollst ndig verschlossener Koronararterienl sionen definiert als L sion der Koronararterie mit TIMI Blutfluss 0 f r mehr als 3 Monate und L sionen der Bifurkat...

Page 11: ...nicht klinischen Tests reicht das vom Produkt verursachte Bildartefakt bei Bildgebung mit einer Gradientenecho oder Spin Echo Pulssequenz und einem 3T MRT System etwa 6 mm ber die XIENCE Sierra Stent...

Page 12: ...Austrittskerbe des F hrungsdrahts flie t Hinweis Die Manipulation des Stents beim Sp len des F hrungsdrahtlumens vermeiden da dadurch die Setzung des Stents am Ballon beeintr chtigt werden kann 9 3 3...

Page 13: ...vollst ndiger Kontakt zur Gef wand vorliegt kann ein gr erer Ballon verwendet werden um den Stent weiter aufzudehnen Der Stent kann mithilfe eines d nnen nicht berdehnbaren Hochdruck Ballonkatheters...

Page 14: ...0 30 0 53 158 0 20 0 40 52 Sp ter Verlust im Segment mm 0 14 0 39 343 0 26 0 46 158 0 16 0 41 52 Bin re Restenose im Stent 2 3 8 343 5 7 9 158 3 8 2 52 Bin re Restenose im Segment 4 7 16 344 8 9 14 15...

Page 15: ...terien XIENCE V Indien ist ein prospektives multizentrisches einarmiges Open Label Beobachtungsregister zur Beurteilung der fortgesetzten Sicherheit und Wirksamkeit des XIENCE V EECSS w hrend der komm...

Page 16: ...PT Unterbrechung Abbruch Die Sicherheit und Wirksamkeit sowie niedrige Stentthromboseraten ST Raten der XIENCE Produktreihe von Stents konnten in verschiedenen Studien mit Hoch und Standardrisikopatie...

Page 17: ...situant l int rieur de petits vaisseaux coronaires des l sions pour lesquelles un traitement entra ne l emprisonnement des branches lat rales l sions avec une branche lat rale de diam tre 2 mm ou une...

Page 18: ...t compatible avec l IRM sous conditions dans des configurations uniques et avec chevauchements d une longueur maximale de 71 mm Un patient portant ce dispositif peut passer un examen IRM dans les cond...

Page 19: ...nflage Ballonnet d angioplastie pour pr dilatation de taille appropri e Ballonnet d angioplastie non compliant pour post dilatation de taille appropri e Robinet trois voies Dispositif de rotation Anti...

Page 20: ...les bandes des marqueurs du ballonnet de la deuxi me endoproth se XIENCE Sierra doivent tre plac es l int rieur de l endoproth se d ploy e avant de proc der au d ploiement 4 V rifier nouveau la posit...

Page 21: ...4 158 9 6 5 52 Remarques Les donn es correspondent la moyenne mm ET ou n N N repr sente le nombre total de patients M repr sente le nombre total de l sions Les essais SPIRIT III et SPIRIT Small Vessel...

Page 22: ...ble RLC induites par isch mie Les essais SPIRIT Small Vessel et SPIRIT PRIME ont utilis la d finition de la RLC cliniquement justifi e plut t que celle de la RLC induite par isch mie L chec du vaissea...

Page 23: ...march XIENCE V USA Phase I 1 an SPIRIT V tude bras unique XIENCE V India 1 an 2 ans 1 an 2 ans XIENCE V N 8040 XIENCE V N 2663 XIENCE V N 2663 XIENCE V N 990 XIENCE V N 990 chec de la l sion cible TL...

Page 24: ...s sur 2 ans N 11 219 Interruption du double traitement antiplaquettaire 30 jours Interruption du double traitement antiplaquettaire 30 jours 730 jours Aucune interruption du double traitement antiplaq...

Page 25: ...tratamiento de pacientes que presenten reestenosis del stent en lesiones de una arteria coronaria lesiones cr nicas en una arteria coronaria con oclusi n total definidas como lesiones en una arteria...

Page 26: ...cuenta las posibles interacciones con f rmacos tanto sist micas como locales en la pared del vaso a la hora de decidir si se coloca el stent XIENCE Sierra a un paciente que est tomando alg n f rmaco...

Page 27: ...e el stent se desplazara del bal n Nota Si se observa aire en el cuerpo repita los pasos 3 a 5 del apartado 9 3 3 Preparaci n del sistema dispensador para evitar la expansi n irregular del stent 9 4 P...

Page 28: ...PRIME Por consiguiente en este apartado se resumen los datos de los ensayos cl nicos para XIENCE V y XIENCE PRIME 10 1 Ensayos cl nicos previos a la comercializaci n Los principales resultados de segu...

Page 29: ...0 1 104 Muerte de origen card aco 0 4 10 2416 0 4 5 1195 0 8 5 657 0 9 3 320 1 5 2 136 0 3 1 399 0 0 0 104 IM 1 9 45 2416 3 1 37 1195 2 7 18 655 4 1 13 319 1 5 2 136 1 8 7 399 4 8 5 104 Muerte de orig...

Page 30: ...e de origen card aco el IM atribuido al vaso tratado y la RLT inducida por isquemia En SPIRIT SV y PRIME se utiliz la definici n de RLT cl nicamente indicada en lugar de la RLT inducida por isquemia E...

Page 31: ...guno Ninguno Ninguno Ninguno Tabla 10 2 2 Resultados cl nicos principales de los ensayos de la familia SPIRIT y XIENCE V posteriores a la comercializaci n XIENCE V USA Fase I 1 a o SPIRIT V SAS XIENCE...

Page 32: ...e 2 a os N 11 219 DAPT interrumpido 30 d as DAPT interrumpido 30 730 d as Sin interrupci n de DAPT Posterior TS seg prob 2 51 12 478 0 38 13 3445 0 66 44 6648 11 0 PRESENTACI N Est ril este dispositiv...

Page 33: ...5 4 0 18 117 3 5 4 0 23 145 3 5 4 0 28 181 3 5 4 0 33 209 3 5 4 0 38 236 Per il trattamento di pazienti che si presentano con ristenosi in stent in lesioni dell arteria coronaria lesioni croniche del...

Page 34: ...E Sierra se rilevato con una sequenza d impulsi gradient echo o spin echo 5 8 Interazioni tra farmaci Vedere la sezione 6 1 Interazioni con farmaci o altre sostanze Alcuni farmaci influiscono sul meta...

Page 35: ...a al rubinetto a tre vie collegarlo a alla porta di gonfiaggio del prodotto Non piegare l ipotubo del prodotto durante il collegamento al dispositivo di gonfiaggio siringa 3 Con la punta rivolta verso...

Page 36: ...li degli altri sistemi di stent Abbott Vascular a scambio rapido RX e degli altri cateteri per dilatazione coronarica Se paragonato a XIENCE V EECSS ed a XIENCE PRIME EECSS XIENCE Sierra EECSS ha gli...

Page 37: ...1 0 1 104 Morte cardiaca 0 4 10 2 416 0 4 5 1 195 0 8 5 657 0 9 3 320 1 5 2 136 0 3 1 399 0 0 0 104 IM 1 9 45 2 416 3 1 37 1 195 2 7 18 655 4 1 13 319 1 5 2 136 1 8 7 399 4 8 5 104 Morte cardiaca o IM...

Page 38: ...ardiaca IM attribuito al vaso target e TLR rivascolarizzazione della lesione target causata da ischemia SPIRIT SV e PRIME hanno impiegato la definizione di TLR indicata clinicamente anzich quella di T...

Page 39: ...gli studi delle famiglie SPIRIT e XIENCE V post commercializzazione XIENCE V USA Fase I 1 anno SPIRIT V SAS XIENCE V India 1 anno 2 anni 1 anno 2 anni XIENCE V N 8 040 XIENCE V N 2 663 XIENCE V N 2 66...

Page 40: ...N 11 219 DAPT interrotta 30 giorni DAPT interrotta da 30 giorni a 730 giorni Nessuna interruzione della DAPT Successiva ST acc prob 2 51 12 478 0 38 13 3 445 0 66 44 6 648 11 0 MODALIT DI FORNITURA S...

Page 41: ...ento de doentes com uma reestenose dentro do stent nas les es da art ria coron ria les es cr nicas da art ria coron ria com oclus o total definidas como les es da art ria coron ria com um fluxo TIMI d...

Page 42: ...ca quando administrado por via oral juntamente com ciclosporina CsA N o foram efetuados estudos formais sobre a intera o com medicamentos com o XIENCE Sierra por causa da exposi o limitada ao everolim...

Page 43: ...to se as bolhas persistirem 7 Se tiver utilizado uma seringa ligar um dispositivo de insufla o preparado torneira 8 Abrir a torneira para o sistema de entrega 9 Manter na posi o neutra Nota N o induzi...

Page 44: ...um desempenho do SSCEE XIENCE Sierra semelhante ao desempenho dos stents XIENCE V e XIENCE PRIME Os dados dos ensaios cl nicos dos stents XIENCE V e XIENCE PRIME s o assim resumidos nesta sec o 10 1...

Page 45: ...3 4 320 1 5 2 136 0 8 3 399 1 0 1 104 Morte Card aca 0 4 10 2416 0 4 5 1195 0 8 5 657 0 9 3 320 1 5 2 136 0 3 1 399 0 0 0 104 EM 1 9 45 2416 3 1 37 1195 2 7 18 655 4 1 13 319 1 5 2 136 1 8 7 399 4 8 5...

Page 46: ...aca EM atribu do ao vaso alvo e TLR causada por isquemia Os ensaios cl nicos SPIRIT SV e PRIME utilizaram a defini o de TLR clinicamente indicada em vez da defini o de TLR causada por isquemia TVF in...

Page 47: ...nt sem braquiterapia pr via m ximo de 4 stents com elui o de everolimus SEE planeados De acordo com a norma de cuidados do centro Tamanho da les o Sem restri es angiogr ficas RVD 2 25 4 0 mm Comprimen...

Page 48: ...et ria Dupla DAPT A gama de stents XIENCE demonstrou seguran a e efic cia em m ltiplos ensaios realizados com doentes reais padr o de baixo risco e de risco alargado e demonstraram baixas taxas de tro...

Page 49: ...23 mm 28 mm 33 mm eller 38 mm med en referensk rldiameter p 2 00 mm och 4 25 mm 3 0 KONTRAINDIKATIONER XIENCE Sierra everolimusavgivande kransk rlsstentsystem r kontraindicerat f r anv ndning till Pat...

Page 50: ...pr vningar F r patienter som f r flera XIENCE Sierra enheter samtidigt kan det dock vara m jligt att systemiska koncentrationer av everolimus tillf lligt n rmar sig immunsuppressiva niv er s rskilt ho...

Page 51: ...ska inte utf ras om stenten inte r korrekt placerad i m llesionen Obs Om avl gsnande av ett stentsystem kr vs f re placering m ste man s kerst lla att guidekatetern r koaxialt placerad i f rh llande...

Page 52: ...00 XIENCE PRIME Totalt 100 XIENCE PRIME Behandling Upp till tv de novo lesioner i olika epikardiella k rl Upp till tre de novo lesioner h gst tv lesioner per epikardiellt k rl Upp till tv de novo lesi...

Page 53: ...h TVR p grund av ischemi vilket anv ndes f r SPIRIT II SPIRIT III och SPIRIT IV MACE inkluderar hj rtd d MI och TLR p grund av ischemi Tabell 10 1 4 SPIRIT sortimentet av kliniska pr vningar huvudsakl...

Page 54: ...XIENCE V USA l ngsiktig uppf ljningskohort XIENCE V USA AV DAPT kohort SPIRIT V SAS XIENCE V India Studietyp design Multicenter Prospektiv Enkelarmad Multicenter Prospektiv Enkelarmad Multicenter Rand...

Page 55: ...DAPT avbrott Sortimentet med XIENCE stentar har uppvisat s kerhet och effekt i flera pr vningar med verkliga patienter med standardrisk l g risk och ut kad risk och uppvisat l ga stenttrombosfrekvens...

Page 56: ...15 mm 18 mm 23 mm 28 mm 33 mm of 38 mm met een referentievatdiameter van 2 00 mm en 4 25 mm 3 0 CONTRA INDICATIES Het XIENCE Sierra everolimus eluerend coronair stentsysteem is gecontra indiceerd voo...

Page 57: ...everolimus kan worden be nvloed door geneesmiddelen die ook van deze routes gebruikmaken Everolimus blijkt ook de klaring van sommige receptplichtige geneesmiddelen te verminderen als het middel oraal...

Page 58: ...ysteem 1 Maak een vulinstrument spuit gereed met verdund contrastmiddel 2 Bevestig een vulinstrument spuit aan de stopkraan bevestig het aan de vulpoort van het product Buig de binnenste slang van het...

Page 59: ...EECSS XIENCE Xpedition EECSS en XIENCE Alpine EECSS De XIENCE Sierra EECSS verschilt alleen wat betreft het stentplaatsingssysteem van de XIENCE Alpine EECSS Het stentplaatsingssysteem van de XIENCE S...

Page 60: ...1 2 8 657 1 3 4 320 1 5 2 136 0 8 3 399 1 0 1 104 Hartdood 0 4 10 2416 0 4 5 1195 0 8 5 657 0 9 3 320 1 5 2 136 0 3 1 399 0 0 0 104 MI 1 9 45 2416 3 1 37 1195 2 7 18 655 4 1 13 319 1 5 2 136 1 8 7 39...

Page 61: ...CE V India is een prospectief open label multicenter observationeel register met n groep waarin de veiligheid en werkzaamheid van de XIENCE V EECSS op lange termijn wordt ge valueerd tijdens commercie...

Page 62: ...daard of laag risico en met hoger risico in alledaagse omstandigheden de aantallen stenttrombose waren laag Dit is inclusief pati nten bij wie de behandeling met twee trombocytenaggregatieremmers DAPT...

Page 63: ...mm 33 mm eller 38 mm med en referencekardiameter p 2 00 mm og 4 25 mm 3 0 KONTRAINDIKATIONER XIENCE Sierra Everolimus eluerende koronarstentsystem er kontraindiceret til brug hos Patienter der ikke ka...

Page 64: ...ke observeret i de kliniske unders gelser SPIRIT og XIENCE stent familien Det er dog muligt at systemiske koncentrationer af everolimus hos patienter som modtager flere XIENCE Sierra anordninger samti...

Page 65: ...se eller l srivelse af stenten Fasthold guidewirens placering p tv rs af l sionen og fjern fremf ringssystemet og guidingkatetret som en enkelt enhed 7 F r fremf ringssystemet frem over guidewiren til...

Page 66: ...10 1 4 viser unders gelsernes design angiografiske resultater for unders gelser der kr vede angiografisk opf lgning og v sentlige kliniske resultater henholdsvis efter 1 r og fra seneste opf lgning T...

Page 67: ...revet TLR 2 3 56 2416 4 6 55 1195 3 4 22 655 5 6 18 319 5 1 7 136 2 5 10 399 2 9 3 104 Isk misk drevet TVR ikke TL 2 2 54 2416 2 4 29 1195 3 2 21 655 4 7 15 319 5 9 8 136 2 8 11 399 2 9 3 104 Stenttro...

Page 68: ...d de novo koronararteriel sioner XIENCE V India er en prospektiv ben observerende multicenterregisterunders gelse med n arm til evaluering af den fortsatte sikkerhed og effektivitet for XIENCE V EECSS...

Page 69: ...siko lav risiko og udvidet risiko og udviste lave rater for stenttrombose ST Dette omfatter patienter der enten holdt op med eller afbr d dobbelt antitrombocytbehandling DAPT efter 1 m ned efter impla...

Page 70: ...42 mm 0 056 12 1216 16 1621 88 3 5 8 12 15 18 23 28 33 38 5 F 1 42 mm 0 056 12 1216 16 1621 84 4 0 8 12 15 18 23 28 33 38 5 F 1 42 mm 0 056 12 1216 16 1621 86 F 9 5 2 0 Everolimus XIENCE Sierra de nov...

Page 71: ...s XIENCE Sierra everolimus XIENCE Sierra 5 9 everolimus XIENCE Sierra SPIRIT XIENCE XIENCE Sierra everolimus CYP3A4 P 5 10 everolimus everolimus XIENCE Sierra SPIRIT XIENCE everolimus 1 Certican 2015...

Page 72: ...IENCE XIENCE PCI PCI PC 9 0 9 1 1 2 3 4 EECSS XIENCE Sierra EECSS XIENCE Sierra 9 2 2 3 10 20 cc 1 000 u 500 cc HepNS 2 44 mm 0 096 0 36 mm 0 014 x 175 cm 1 1 9 3 9 3 1 1 RX 2 9 3 2 1 HepNS 9 3 3 1 2...

Page 73: ...SS XIENCE Sierra EECSS XIENCE V XIENCE PRIME XIENCE Xpedition XIENCE Alpine EECSS XIENCE Sierra EECSS XIENCE PRIME XIENCE Xpedition XIENCE Alpine EECSS XIENCE Sierra EECSS XIENCE Alpine XIENCE Sierra...

Page 74: ...novo RVD 2 5 3 75 mm 28 mm RVD 2 5 4 25 mm2 28 mm RVD 2 25 2 50 mm 28 mm RVD 2 25 4 25 mm 22 mm XIENCE PRIME CS RVD 2 25 4 25 mm 22 mm XIENCE PRIME LL RVD 2 5 4 25 mm 22 mm 32 mm 240 1 TLR TLF 1 TLF 1...

Page 75: ...9 3 320 1 5 2 136 0 3 1 399 0 0 0 104 1 9 45 2416 3 1 37 1195 2 7 18 655 4 1 13 319 1 5 2 136 1 8 7 399 4 8 5 104 2 2 54 2416 3 3 39 1195 3 4 22 655 4 7 15 319 2 9 4 136 2 0 8 399 4 8 5 104 TLR 2 3 56...

Page 76: ...0 0 0 104 3 1 73 2348 4 7 55 1158 4 6 28 605 7 0 20 286 1 5 2 133 1 8 7 399 4 8 5 104 4 5 105 2348 6 0 70 1158 7 1 43 605 11 2 32 286 3 0 4 133 2 0 8 399 4 8 5 104 TLR 6 3 148 2348 7 9 92 1158 8 9 54...

Page 77: ...VR 7 04 185 2627 10 34 265 2562 ARC 7 2 545 7522 4 23 111 2627 5 74 147 2562 1 9 19 986 2 8 26 942 3 3 249 7505 TLR 4 6 349 7522 1 90 50 2627 3 04 78 2562 1 2 12 986 1 5 14 942 TVR TLR 2 3 176 7522 1...

Page 78: ...SPIRIT IV SPIRIT V SPIRIT XIENCE V XIENCE V 10 3 1 ARC DAPT 730 7 7 2 N 11 219 DAPT 30 DAPT 30 730 DAPT ST 2 51 12 478 0 38 13 3445 0 66 44 6648 11 0 1 Everolimus XIENCE Sierra 25 C 77 F 15 30 C 59 86...

Page 79: ...z stupca v Eur pskom spolo enstve Outer diameter rednica zewn trzna K ls tm r Vn j pr m r D ap Vonkaj priemer Inner diameter rednica wewn trzna Bels tm r Vnit n pr m r ap Vn torn priemer Stent length...

Page 80: ...18 117 3 5 4 0 23 145 3 5 4 0 28 181 3 5 4 0 33 209 3 5 4 0 38 236 u pacjent w u kt rych wyst pi a restenoza w stencie za o onym w zw onym odcinku t tnicy wie cowej przewlek e zmiany charakteryzuj ce...

Page 81: ...a z zastosowaniem sekwencji echa gradientowego lub sekwencji impuls w echa spinowego i systemu obrazowania rezonansem magnetycznym o indukcyjno ci pola magnetycznego 3 T 5 8 Interakcje z lekami Patrz...

Page 82: ...i zast pi go innym Post powa zgodnie z procedur zwracania produkt w w przypadku nieu ytego urz dzenia 9 3 2 P ukanie kana u prowadnika 1 Kana prowadnika przep ukiwa roztworem HepNS dop ki p yn nie za...

Page 83: ...ak w przypadku innych system w stentu RX firmy Abbott Vascular i wie cowych cewnik w rozszerzaj cych W por wnaniu do wyrob w XIENCE V EECSS i XIENCE PRIME EECSS system XIENCE Sierra EECSS posiada iden...

Page 84: ...2416 3 3 39 1195 3 4 22 655 4 7 15 319 2 9 4 136 2 0 8 399 4 8 5 104 TLR spowodowana niedokrwieniem 2 3 56 2416 4 6 55 1195 3 4 22 655 5 6 18 319 5 1 7 136 2 5 10 399 2 9 3 104 TVR spowodowana niedokr...

Page 85: ...iany docelowej TLR z powodu niedokrwienia W badaniach SPIRIT SV i PRIME stosowano definicj ponownej rewaskularyzacji stentowanego odcinka TLR ze wskaza klinicznych a nie TLR spowodowanej niedokrwienie...

Page 86: ...us EES Zgodnie ze standardami obowi zuj cymi w plac wce opieki Wielko zmiany Brak ogranicze dotycz cych angiografii RVD 2 25 4 0 mm D ugo 28 mm na podstawie oceny wizualnej Brak ogranicze dotycz cych...

Page 87: ...IENCE wykaza a bezpiecze stwo i skuteczno stosowania w rzeczywistej praktyce medycznej co stwierdzono na podstawie wielu r nych bada klinicznych u pacjent w o standardowym niskim ryzyku oraz pacjent w...

Page 88: ...zi hossznak minden esetben r videbbnek kell lennie a n vleges sztenthosszn l 8 mm 12 mm 15 mm 18 mm 23 mm 28 mm 33 mm vagy 38 mm 2 00 mm s 4 25 mm k z tti referenciav red ny tm r mellett 3 0 ELLENJAV...

Page 89: ...zott m rt k Ez rt amikor a XIENCE Sierra sztent be ltet s re vonatkoz d nt st m rlegelik egy olyan beteg eset n aki az everolimusszal ismerten k lcs nhat sba l p gy gyszert szed vagy ha egy XIENCE Sie...

Page 90: ...zi jellemz i alapj n kell d nteni Ha el t g t st v geznek korl tozni kell a PTCA ballonnal t rt n el t g t s hossz t hogy elker lhet legyen a XIENCE Sierra sztent ter let n k v li rs r l s 3 Hossz l z...

Page 91: ...sg lattal llap tott k meg A SPIRIT III RCT volt a legfontosabb randomiz lt klinikai vizsg lat RCT amely meg llap totta a XIENCE V sztent TAXUS Express sztenthez TAXUS sztent viszony tott egyen rt k s...

Page 92: ...9 1 0 1 104 Sz vhal l 0 4 10 2416 0 4 5 1195 0 8 5 657 0 9 3 320 1 5 2 136 0 3 1 399 0 0 0 104 MI 1 9 45 2416 3 1 37 1195 2 7 18 655 4 1 13 319 1 5 2 136 1 8 7 399 4 8 5 104 Sz vhal l vagy MI 2 2 54 2...

Page 93: ...jes tm ny nek tov bbi felm r se volt de novo sz vkoszor r l zi kkal rendelkez betegek kezel s ben A XIENCE V India egy prospekt v ny lt multicentrikus megfigyel ses egykaros regiszter a XIENCE V EECSS...

Page 94: ...zsg lat sor n bizony totta biztons goss g t s hat soss g g t tov bb ezen eszk z k mellett a sztenttromb zis stent thrombosis ST el fordul si ar nya is alacsonynak bizonyult Ebbe beletartoznak azok a b...

Page 95: ...rn ch art ri definovan jako l ze koron rn ch art ri s pr tokem TIMI 0 trvaj c d le ne 3 m s ce a l ze bifurkace koron rn art rie Ve v ech p padech mus b t d lka o et ovan l ze men ne nomin ln d lka st...

Page 96: ...insuficienci funkce jater nebo kte u vaj l ky inhibuj c CYP3A4 nebo p glykoprotein Proto je zapot eb v novat pozornost pacient m u vaj c m jin imunosupresivn p pravky nebo pacient m ohro en m potla e...

Page 97: ...pr vn um st n v c lov l zi nesm se prov st jeho expanze Pozn mka Pokud je nutn stent vyjmout je t p ed rozvinut m ujist te se e je vodic katetr um st n v jedn linii se zav d c m syst mem stentu a syst...

Page 98: ...press kontrola 1 2301 Celkem 150 XIENCE V 2 25 mm Celkem 400 XIENCE PRIME Celkem 100 XIENCE PRIME L ba A dv l ze de novo v r zn ch epikardi ln ch c v ch A t i l ze de novo maxim ln dv l ze na epikardi...

Page 99: ...55 1195 3 4 22 655 5 6 18 319 5 1 7 136 2 5 10 399 2 9 3 104 Ischemi vyvolan TVR mimo c lovou l zi 2 2 54 2416 2 4 29 1195 3 2 21 655 4 7 15 319 5 9 8 136 2 8 11 399 2 9 3 104 Tromb za stentu Definice...

Page 100: ...sla v t to tabulce odpov daj po tu pacient Pacient je zapo t n pro ka dou ud lost a ka d asov obdob pouze jedenkr t Do daj v ech hodnocen se po taj i hodnoty za okno tolerance 28 dn K TLF pat srde n...

Page 101: ...edchoz brachyterapie max 4 pl novan EES Podle standardn p e pracovi t Velikost l ze Bez angiografick ch omezen RVD 2 25 4 0 mm D lka 28 mm podle vizu ln ho odhadu Bez angiografick ch omezen Prim rn c...

Page 102: ...K TLF pat srde n smrt infarkt myokardu p isouzen c lov c v podle definice protokolu a klinicky indikovan TLR 10 3 Anal za hrnu klinick ch hodnocen pro tromb zu stentu po p eru en ukon en l by DAPT ad...

Page 103: ...ir Operasyonel antikoag lasyon veya operasyon sonras antiplatelet rejimine kar alerji veya a r duyarl l k da dahil olmak zere tolere edemeyen hastalar Everolimus veya yap sal olarak ili kili bile ikle...

Page 104: ...risi klinik ara t rmalarda ba kl k sistemi bask lanmas g zlemlenmemi tir Ancak ayn anda birden fazla XIENCE Sierra cihaz uygulanan hastalar i in zellikle ayn zamanda karaci er yetmezli i olan ya da CY...

Page 105: ...erhangi bir anda ola and bir diren hissedilecek olursa k lavuz kateter ve stent yerle tirme sisteminin tamam tek bir nite olarak kart lmal d r Bu i lem floroskopiyle do rudan g r nt leme alt nda yap l...

Page 106: ...k Yok Yok Klinik Takip 30 180 240 270 g n 1 5 y l 30 180 270 g n 1 3 y l 30 g n 240 g n 1 3 y l 30 180 g n 1 3 y l 30 180 g n 1 3 y l Anjiyografik Takip 240 g n N 564 Yok 240 g n N 69 Yok Yok 1 TAXUS...

Page 107: ...fi de novo koroner arter lezyonlar olan hastalar n tedavisinde XIENCE V EECSS performans n de erlendirmeye devam etmektir XIENCE V Hindistan Hindistan da ger e e uygun senaryolarda ticari kullan m s r...

Page 108: ...ger ek hasta al malar nda g venli ini ve etkinli ini g stermi ve d k stent trombozu ST oranlar g stermi tir Buna koroner stent implantasyonunun 1 ay ndan sonra ikili antitromboz tedavisini DAPT b raka...

Page 109: ...3 5 4 0 12 72 3 5 4 0 15 99 3 5 4 0 18 117 3 5 4 0 23 145 3 5 4 0 28 181 3 5 4 0 33 209 3 5 4 0 38 236 Vo v etk ch pr padoch by d ka o etrovanej l zie mala by men ia ako menovit d ka stentu 8 mm 12 m...

Page 110: ...inn l tka stentu XIENCE Sierra je imunosupres vum V klinick ch sk aniach typov ho radu stentov SPIRIT a XIENCE nebola pozorovan imunosupresia U pacientov ktor m bolo naraz implantovan ch nieko ko ste...

Page 111: ...dzaciemu syst mu udr ujte neutr lny tlak Oto n hemostatick ventil otvorte naj ir ie ako sa d 5 Zav dzac syst m nasa te sp na proxim lnu as vodiaceho dr tu udr iavajte pri tom polohu vodiaceho dr tu po...

Page 112: ...jadra stentov ho syst mu XIENCE PRIME a XIENCE PRIME LL pri ktorom sa preuk zala bezpe nos a innos stentov XIENCE PRIME a XIENCE PRIME LL Tabu ky 10 1 1 a 10 1 4 predstavuj koncepcie sk ania angiogra...

Page 113: ...2 3 56 2416 4 6 55 1195 3 4 22 655 5 6 18 319 5 1 7 136 2 5 10 399 2 9 3 104 TVR sp soben isch miou nie TL 2 2 54 2416 2 4 29 1195 3 2 21 655 4 7 15 319 5 9 8 136 2 8 11 399 2 9 3 104 Tromb za stentu...

Page 114: ...India je prospekt vny otvoren multicentrick pozorovac jednovetvov register na hodnotenie trvalej bezpe nosti a innosti XIENCE V EECSS pri komer nom pou it v re lnych podmienkach v Indii V tabulk ch 1...

Page 115: ...on en du lnej antiagrega nej terapie DAPT Typov rad stentov XIENCE preuk zal bezpe nos a innos vo viacer ch sk aniach s be n mi resp n zkorizikov mi a vysokorizikov mi skuto n mi pacientmi a pouk zal...

Page 116: ...ean Valtuutettu edustaja Euroopan yhteis ss Outer diameter Diametru exterior Ulkol pimitta Inner diameter Diametru interior Sis l pimitta Stent length Lungimea stentului Stentin pituus Guiding cathete...

Page 117: ...42 mm 12 1216 16 1621 88 3 5 8 12 15 18 23 28 33 38 5F 0 056 1 42 mm 12 1216 16 1621 84 4 0 8 12 15 18 23 28 33 38 5F 0 056 1 42 mm 12 1216 16 1621 86 F 9 5 2 0 XIENCE Sierra everolimus de novo 12 jai...

Page 118: ...mus XIENCE Sierra 5 9 Everolimus a XIENCE Sierra SPIRIT XIENCE a XIENCE Sierra everolimus CYP3A4 5 10 everolimus everolimus a XIENCE Sierra SPIRIT XIENCE everolimus 6 0 6 1 Everolimus P4503A4 CYP3A4 P...

Page 119: ...r 2014 Votubia 2014 Afinitor 2015 Zortress 2015 www MHRA gov uk www ema europa eu www fda gov PCI PCI 9 0 9 1 1 2 3 4 XIENCE Sierra EECSS XIENCE Sierra EECSS 9 2 2 3 10 20 cc 1000 u 500 cc HepNS 0 096...

Page 120: ...NCE V TAXUS Express TAXUS SPIRIT IV XIENCE V TAXUS Express TAXUS de novo 28 mm 2 5 mm 4 25 mm SPIRIT IV XIENCE V TAXUS Express SPIRIT SV XIENCE V 2 25 mm SPIRIT PRIME XIENCE PRIME XIENCE PRIME LL XIEN...

Page 121: ...33 319 8 1 11 136 4 5 18 399 7 7 8 104 1 0 25 2416 1 3 15 1195 1 2 8 657 1 3 4 320 1 5 2 136 0 8 3 399 1 0 1 104 0 4 10 2416 0 4 5 1195 0 8 5 657 0 9 3 320 1 5 2 136 0 3 1 399 0 0 0 104 1 9 45 2416 3...

Page 122: ...73 2348 4 7 55 1158 4 6 28 605 7 0 20 286 1 5 2 133 1 8 7 399 4 8 5 104 4 5 105 2348 6 0 70 1158 7 1 43 605 11 2 32 286 3 0 4 133 2 0 8 399 4 8 5 104 TLR 6 3 148 2348 7 9 92 1158 8 9 54 605 12 9 37 28...

Page 123: ...T SPIRIT V SAS XIENCE V 8040 4663 868 2663 977 18 de novo 4 everolimus 2 25 4 0 mm 28 mm ARC 1 ARC 1 5 MACE 12 33 TVR 30 ARC 1 3 1 1 5 ARC 12 33 1 14 30 180 1 2 3 4 15 24 30 33 30 1 2 14 30 180 1 2 3...

Page 124: ...1 45 2627 2 97 76 2562 0 9 9 986 1 7 16 942 1 4 108 7522 1 10 29 2627 1 87 48 2562 0 9 9 986 1 7 16 942 ARC 6 3 475 7522 3 54 93 2627 4 45 114 2562 1 3 13 986 1 6 15 942 2 2 162 7505 ARC 0 81 60 7380...

Page 125: ...2 72 3 5 4 0 15 99 3 5 4 0 18 117 3 5 4 0 23 145 3 5 4 0 28 181 3 5 4 0 33 209 3 5 4 0 38 236 n toate cazurile lungimea leziunii tratate ar trebui s fie mai mic dec t lungimea nominal a stentului 8 mm...

Page 126: ...medical atunci c nd a fost administrat pe cale oral mpreun cu ciclosporina CsA Nu au fost realizate studii formale privind interac iunile medicamentoase cu stentul XIENCE Sierra din cauza expunerii l...

Page 127: ...de la 3 la 5 p n c nd este eliminat tot aerul Nu utiliza i produsul dac bulele de aer persist 7 Dac a fost utilizat o sering ata a i la robinet un dispozitiv de umflare preg tit 8 Deschide i robinetul...

Page 128: ...XIENCE PRIME De aceea datele provenite din studiile clinice pentru XIENCE V i XIENCE PRIME sunt prezentate pe scurt n aceast sec iune 10 1 Studii clinice pre comercializare Siguran a i eficacitatea pr...

Page 129: ...2 5 10 399 2 9 3 104 TVR determinat de ischemie non TL 2 2 54 2416 2 4 29 1195 3 2 21 655 4 7 15 319 5 9 8 136 2 8 11 399 2 9 3 104 Tromboz de stent ARC stabilit probabil 0 29 7 2391 1 10 13 1181 0 9...

Page 130: ...acela de a continua evaluarea performan elor XIENCE V EECSS n tratarea pacien ilor cu leziuni de novo ale arterelor coronare XIENCE V India este un registru prospectiv deschis multicentric observa io...

Page 131: ...stenturi XIENCE a demonstrat siguran i eficacitate n multiple studii clinice cu pacien i reali cu riscuri standard sc zute i extinse i a demonstrat rate de tromboz de stent ST sc zute Aceasta include...

Page 132: ...16 16 1621 87 3 25 8 12 15 18 23 28 33 38 5 F 0 056 1 42 12 1216 16 1621 88 3 5 8 12 15 18 23 28 33 38 5 F 0 056 1 42 12 1216 16 1621 84 4 0 8 12 15 18 23 28 33 38 5 F 0 056 1 42 12 1216 16 1621 86 Fr...

Page 133: ...Sierra 3 5 8 6 1 P4503A4 CYP3A4 P PgP XIENCE Sierra XIENCE Sierra XIENCE Sierra 1 Certican 2015 Afinitor 2014 Votubia 2014 Afinitor 2015 Zortress 2015 www MHRA gov uk www ema europa eu www fda gov 5...

Page 134: ...American College of Cardiology ACC American Heart Association AHA Society for Cardiovascular Angiography and Interventions SCAI ESC XIENCE DAPT DAPT XIENCE DAPT XIENCE 9 0 9 1 1 2 3 4 XIENCE Sierra X...

Page 135: ...XIENCE Xpedition XIENCE Alpine XIENCE Sierra XIENCE Alpine XIENCE Sierra RX Abbott Vascular XIENCE V XIENCE PRIME XIENCE Sierra XIENCE Sierra 28 XIENCE Sierra XIENCE PRIME XIENCE V XIENCE Sierra XIENC...

Page 136: ...NCE PRIME LL RVD 2 5 4 25 22 32 240 1 TLR TLF 1 TLF 1 TLF 1 TVF 270 30 180 240 270 1 5 30 180 270 1 3 30 240 1 3 30 180 1 3 30 180 1 3 240 N 564 240 N 69 1 TAXUS 1 1 TAXUS Libert 2 RVD 2 5 3 75 3 5 TA...

Page 137: ...8 5 657 0 9 3 320 1 5 2 136 0 3 1 399 0 0 0 104 1 9 45 2416 3 1 37 1195 2 7 18 655 4 1 13 319 1 5 2 136 1 8 7 399 4 8 5 104 2 2 54 2416 3 3 39 1195 3 4 22 655 4 7 15 319 2 9 4 136 2 0 8 399 4 8 5 104...

Page 138: ...399 0 0 0 104 3 1 73 2348 4 7 55 1158 4 6 28 605 7 0 20 286 1 5 2 133 1 8 7 399 4 8 5 104 4 5 105 2348 6 0 70 1158 7 1 43 605 11 2 32 286 3 0 4 133 2 0 8 399 4 8 5 104 TLR 6 3 148 2348 7 9 92 1158 8...

Page 139: ...V USA AV DAPT SPIRIT V SAS XIENCE V India 8040 4663 868 2663 977 18 de novo 4 2 25 4 0 28 ARC 1 ARC 1 5 MACE 12 33 TVR 30 ARC 1 3 1 1 5 ARC 12 33 1 14 30 180 1 2 3 4 15 24 30 33 30 1 2 14 30 180 1 2 3...

Page 140: ...97 76 2562 0 9 9 986 1 7 16 942 1 4 108 7522 1 10 29 2627 1 87 48 2562 0 9 9 986 1 7 16 942 ARC 6 3 475 7522 3 54 93 2627 4 45 114 2562 1 3 13 986 1 6 15 942 2 2 162 7505 ARC 0 81 60 7380 0 65 17 260...

Page 141: ...entin l pimitta mm Stentin pituus mm L keannos g 3 5 4 0 8 53 3 5 4 0 12 72 3 5 4 0 15 99 3 5 4 0 18 117 3 5 4 0 23 145 3 5 4 0 28 181 3 5 4 0 33 209 3 5 4 0 38 236 Kaikissa tapauksissa hoidetun leesi...

Page 142: ...suudet voivat heill l hesty v liaikaisesti immunosuppressiivisia arvoja erityisesti potilailla joilla on my s maksan vajaatoimintaa tai jotka k ytt v t CYP3A4 sytokromia tai P glykoproteiinia est vi l...

Page 143: ...ntti tulee ulos ohjainkatetrista l vie j rjestelm v kisin eteenp in Vastus saattaa olla merkkin ongelmasta ja liiallisen voiman k ytt saattaa vaurioittaa stentti ja saada sen siirtym n paikaltaan Pid...

Page 144: ...eri Kliininen SPIRIT PRIME tutkimus P kokojen rekisteri Pitk n leesion rekisteri Tutkimustyyppi suunnitelma Monikeskuksinen Satunnaistettu Yks issokkoutettu Aktiivikontrolloitu Monikeskuksinen Satunna...

Page 145: ...miaper inen kohdeleesion uudelleenahtauma 2 3 prosenttia 56 2 416 4 6 prosenttia 55 1 195 3 4 prosenttia 22 655 5 6 prosenttia 18 319 5 1 prosenttia 7 136 2 5 prosenttia 10 399 2 9 prosenttia 3 104 Is...

Page 146: ...hokkuutta todellisessa k yt ss sen j lkeen kun se tuli markkinoille Yhdysvalloissa ja jossa my s tuetaan FDA n DAPT koskevaa aloitetta Yksiryhm isen SPIRIT V tutkimuksen tavoitteena oli jatkaa XIENCE...

Page 147: ...F sis lt syd nkuoleman kohdesuoneen liittyv n syd ninfarktin tutkimussuunnitelman m rityksen mukainen ja kliinisesti indisoidun TLR n 10 3 Kliinisten tutkimusten yhdistelm analyysi stentin tromboosist...

Page 148: ...vnik v Evropski skupnosti Outer diameter Ytre diameter V lisdiameeter r jais diametrs I orinis skersmuo Zunanji premer Inner diameter Indre diameter Sisediameeter Iek jais diametrs Vidinis skersmuo No...

Page 149: ...verolimuseluerende koronarstentsystem er kontraindisert for bruk hos Pasienter som ikke kan tolerere inkludert allergi eller overf lsomhet for prosedyrerelatert antikoagulasjon eller blodplatehemmende...

Page 150: ...rsiktighet med pasienter som tar andre immunsuppressive midler eller som er utsatt for immunsuppresjon 5 10 Potensiale for lipid kning Oral bruk av everolimus hos nyretransplanterte pasienter og pasie...

Page 151: ...u p se at ledekateteret er plassert koaksialt i forhold til stentutleggingssystemet og trekke stentutleggingssystemet forsiktig tilbake i ledekateteret Hvis unormal motstand merkes n r stenten trekkes...

Page 152: ...180 240 270 dager 1 til 5 r 30 180 270 dager 1 til 3 r 30 dager 240 dager 1 til 3 r 30 180 dager 1 til 3 r 30 180 dager 1 til 3 r Angiografisk oppf lging 240 dager N 564 Ingen 240 dager N 69 Ingen Ing...

Page 153: ...joner XIENCE V India er en prospektiv pen flersenter observasjonsstudie med n enkelt gruppe for evaluere kontinuerlig sikkerhet og effekt av XIENCE V EECSS ved kommersiell reell bruk i India Tabell 10...

Page 154: ...se av kliniske studier for stenttrombose etter DAPT avbrudd seponering XIENCE familien av stenter har vist sikkerhet og effekt i flere studier hos reelle pasienter med standard lav risiko og utvidet r...

Page 155: ...2 00 mm kuni 4 25 mm 3 0 VASTUN IDUSTUSED Everoliimust elueeriv p rgarteri stendis steem XIENCE Sierra on vastun idustatud j rgmistel juhtudel Patsiendid kes allergia v i litundlikkuse t ttu ei talu...

Page 156: ...uluvate patsientide v i muid immunosupressante v tvate patsientide korral olla ettevaatlik 5 10 Lipiidide hulga t usu potentsiaal Suukaudset everoliimust kasutatakse neerusiirdamise korral ja kaugelea...

Page 157: ...uleb enne stendi paigaldamist eemaldada paigutage juhtkateeter stendi sisestuss steemiga koaksiaalselt ning t mmake stendi sisestuss steem ettevaatlikult juhtkateetrisse Kui tunnete stendi juhtkateetr...

Page 158: ...e novo kahjustust erinevates epikardiaalsetes veresoontes Kuni kolm de novo kahjustust kuni kaks kahjustust igas epikardiaalses veresoones Kuni kaks de novo kahjustust erinevates epikardiaalsetes vere...

Page 159: ...4 Stenditromboos ARC kindel t en oline 0 29 7 2391 1 10 13 1181 0 9 6 650 0 6 2 316 1 5 2 136 0 5 2 399 0 0 0 104 ARC kindel 0 3 6 2385 0 8 10 1183 0 8 5 650 0 3 1 317 0 7 1 138 0 5 2 399 0 0 0 104 M...

Page 160: ...p rgarteri kahjustustega patsientide ravis XIENCE V India on prospektiivne avatud mitmekeskuseline vaatluslik he haruga registriuuring et hinnata stendi XIENCE V EECSS j tkuvat ohutust ja t husust re...

Page 161: ...as Stendiperekonna XIENCE ohutus ja t husus on ilmnenud mitmes standardse madala riskiga ja suurema riskiga reaalsete patsientide uuringus Ilmnenud on ka stenditromboosi ST madal esinemissagedus See h...

Page 162: ...sinsvada diametram j b t 2 00 mm un 4 25 mm 3 0 KONTRINDIK CIJAS XIENCE Sierra everol mu izdalo a koron r stenta sist ma ir kontrindic ta pacientiem kam ir nepanes ba aler ija vai pastiprin ta jut ba...

Page 163: ...amu everol mu pacientiem kam ir p rst d ta niere vai progres jo a nieru nu karcinoma konstat ja saist bu ar paaugstin tu holester na un triglicer du l meni serum da os gad jumos vi i bija j rst Ietekm...

Page 164: ...et stenta pieg des sist mu vad t jkatetr Ja velkot stentu virzien uz vad t jkatetru rodas neparasta pretest ba stenta pieg des sist ma un vad t jkatetrs ir j izvelk abi kop Tas j veic ar tie as vizual...

Page 165: ...IENCE V 2460 TAXUS Express kontrolgrupa 12301 Kop 150 2 25 mm XIENCE V Kop 400 XIENCE PRIME Kop 100 XIENCE PRIME rst ana L dz diviem de novo boj jumiem da dos epikarda asinsvados L dz trim de novo boj...

Page 166: ...2 3 56 2416 4 6 55 1195 3 4 22 655 5 6 18 319 5 1 7 136 2 5 10 399 2 9 3 104 I mijas ierosin ta TVT rpus TL 2 2 54 2416 2 4 29 1195 3 2 21 655 4 7 15 319 5 9 8 136 2 8 11 399 2 9 3 104 Stenta tromboze...

Page 167: ...cientus ar de novo koron r s art rijas boj jumiem XIENCE V India ir perspekt vs atkl ts daudzcentru nov ro anas vienas grupas re istrs lai nov rt tu XIENCE V EECSS ilglaic gu dro umu un efektivit ti k...

Page 168: ...zos p t jumos gan standarta gan zema riska un papla in ta riska pacientiem re los apst k os k ar uzr d ja zemus stentu trombozes ST l me us Tas ietver pacientus kas piln b vai uz laiku p rtrauca du lo...

Page 169: ...mm kai standartin s kraujagysl s skersmuo yra 2 00 mm ir 4 25 mm 3 0 KONTRAINDIKACIJOS XIENCE Sierra everolim i skirian io vainikin s arterijos stento sistema kontraindikuotina naudoti Pacientams kuri...

Page 170: ...10 Galimas lipid padid jimas Per burn vartojamo everolimo skyrimas pacientams kuriems persodintas inkstas ir pa engusi inksto l steli karcinoma susij s su padid jusia cholesterolio ir triglicerid kon...

Page 171: ...eikia i imti kaip vien prietais Tai darykite tiesiogiai steb dami fluoroskopu 8 U darykite besisukant hemostatin vo tuv Dabar stentas paruo tas i skleisti 9 5 I skleidimo proced ra D MESIO Stento vidi...

Page 172: ...NCE V 2 460 TAXUS Express kontrol 1 2301 I viso 150 2 25 mm XIENCE V I viso 400 XIENCE PRIME I viso 100 XIENCE PRIME Gydymas Iki dviej de novo pa eidim skirtingose epikardin se kraujagysl se Iki trij...

Page 173: ...4 136 2 0 8 399 4 8 5 104 I eminis TLR 2 3 56 2416 4 6 55 1195 3 4 22 655 5 6 18 319 5 1 7 136 2 5 10 399 2 9 3 104 I eminis TVR ne TL 2 2 54 2416 2 4 29 1195 3 2 21 655 4 7 15 319 5 9 8 136 2 8 11 39...

Page 174: ...spektyvinis atviras daugiacentris steb jimo vienos grup s registras skirtas XIENCE V EECSS nuolatiniam saugumui ir veiksmingumui vertinti komerci kai naudojant realiomis s lygomis Indijoje 10 2 1 10 2...

Page 175: ...dartin s ma os rizikos bei i pl stin s rizikos reali pacient tyrim buvo nustatytas XIENCE grup s stent saugumas ir veiksmingumas taip pat buvo nustatytas ma as stento tromboz s ST da nis Tai apima pac...

Page 176: ...rih mora biti dol ina zdravljene lezije manj a od nazivne dol ine stenta 8 mm 12 mm 15 mm 18 mm 23 mm 28 mm 33 mm ali 38 mm pri referen nem premeru ile med 2 00 mm in 4 25 mm 3 0 KONTRAINDIKACIJE Sist...

Page 177: ...ki jemljejo zdravila ki zavirajo CYP3A4 ali P glikoprotein Zato je potrebna previdnost pri bolnikih ki jemljejo druge imunosupresive ali pri katerih obstaja tveganje za imunsko supresijo 5 10 Mo nost...

Page 178: ...ti glejte razdelek 9 6 Postopek odstranjevanja Ozna evalca na balonu nakazujeta robove stenta in meje balona S irjenjem stenta ne smete za eti e stent ni ustrezno name en v ciljni leziji Opomba e je p...

Page 179: ...le encev skupno 1 002 XIENCE V 668 kontrola TAXUS Express 334 skupno 3 690 XIENCE V 2 460 kontrola TAXUS Express 1 2301 skupno 150 2 25 mm XIENCE V skupno 400 XIENCE PRIME skupno 100 XIENCE PRIME Zdra...

Page 180: ...4 29 1195 3 2 21 655 4 7 15 319 5 9 8 136 2 8 11 399 2 9 3 104 Tromboza stenta po ARC definitivna verjetna 0 29 7 2391 1 10 13 1181 0 9 6 650 0 6 2 316 1 5 2 136 0 5 2 399 0 0 0 104 po ARC definitivn...

Page 181: ...a Odpoved ciljne lezije TLF vklju uje sr no smrt miokardni infarkt pripisan ciljni ili in z ishemijo povzro eno revaskularizacijo ciljne lezije TLR tudiji SPIRIT SV in PRIME sta namesto z ishemijo pov...

Page 182: ...1 leto SPIRIT V SAS XIENCE V India 1 leto 2 leti 1 leto 2 leti XIENCE V N 8040 XIENCE V N 2663 XIENCE V N 2663 XIENCE V N 990 XIENCE V N 990 Odpoved ciljne lezije TLF po ARC 9 4 707 7522 5 25 138 2627...

Page 183: ...rezultati N 11 219 DAPT prekinjena v 30 dneh DAPT prekinjena v 30 730 dneh Brez prekinitve DAPT Poznej a tromboza stenta def verj 2 51 12 478 0 38 13 3445 0 66 44 6648 11 0 VSEBINA OB DOBAVI Sterilno...

Page 184: ...the European Community Perwakilan resmi di komunitas Eropa Outer diameter Outer diameter Inner diameter Inner diameter Stent length Stent length Guiding catheter Guiding catheter Non pyrogenic Non pyr...

Page 185: ...16 1621 87 3 25 8 12 15 18 23 28 33 38 5F 0 056 1 42 12 1216 16 1621 88 3 5 8 12 15 18 23 28 33 38 5F 0 056 1 42 12 1216 16 1621 84 4 0 8 12 15 18 23 28 33 38 5F 0 056 1 42 12 1216 16 1621 86 F 9 5 2...

Page 186: ...ENCE Sierra SPIRIT XIENCE XIENCE Sierra CYP3A4 P 5 10 XIENCE Sierra SPIRIT XIENCE 6 0 6 1 P4503A4 CYP3A4 CsA CYP3A4 XIENCE Sierra XIENCE V 1 Certican UK label Mar 2015 Afinitor EU authorization SPC De...

Page 187: ...ss US label Sept 2015 www MHRA gov uk www ema europa eu www fda gov SPC 9 0 9 1 1 2 3 4 XIENCE Sierra EECSS XIENCE Sierra EECSS 9 2 2 3 10 20 HepNS 1000 500 0 096 2 44 0 014 0 36 x 175 1 1 9 3 9 3 1 1...

Page 188: ...US Express TAXUS SPIRIT IV XIENCE V TAXUS Express TAXUS de novo 28 2 5 4 25 SPIRIT IV XIENCE V TAXUS Express SPIRIT Small Vessel SV Registry XIENCE V 2 25 SPIRIT PRIME XIENCE PRIME XIENCE PRIME LL XIE...

Page 189: ...10 3 33 319 8 1 11 136 4 5 18 399 7 7 8 104 1 0 25 2416 1 3 15 1195 1 2 8 657 1 3 4 320 1 5 2 136 0 8 3 399 1 0 1 104 0 4 10 2416 0 4 5 1195 0 8 5 657 0 9 3 320 1 5 2 136 0 3 1 399 0 0 0 104 1 9 45 24...

Page 190: ...99 0 0 0 104 3 1 73 2348 4 7 55 1158 4 6 28 605 7 0 20 286 1 5 2 133 1 8 7 399 4 8 5 104 4 5 105 2348 6 0 70 1158 7 1 43 605 11 2 32 286 3 0 4 133 2 0 8 399 4 8 5 104 TLR 6 3 148 2348 7 9 92 1158 8 9...

Page 191: ...NCE V USA AV SPIRIT V XIENCE V India 8040 4663 868 2663 977 18 de novo 4 2 25 4 0 28 ARC 1 ARC 1 5 MACE 12 33 TVR 30 ARC 1 3 1 1 5 ARC 12 33 1 14 30 180 1 2 3 4 15 24 30 33 30 1 2 14 30 180 1 2 3 EL21...

Page 192: ...7522 1 71 45 2627 2 97 76 2562 0 9 9 986 1 7 16 942 1 4 108 7522 1 10 29 2627 1 87 48 2562 0 9 9 986 1 7 16 942 ARC 6 3 475 7522 3 54 93 2627 4 45 114 2562 1 3 13 986 1 6 15 942 2 2 162 7505 ARC 0 81...

Page 193: ...2 mm 15 mm 18 mm 23 mm 28 mm 33 mm atau 38 mm dengan reference vessel diameter 2 00 mm dan 4 25 mm 3 0 KONTRAINDIKASI XIENCE Sierra Everolimus Eluting Coronary Stent System sebaiknya tidak digunakan p...

Page 194: ...saat ini ini mendapatkan Stent XIENCE Sierra 5 9 Kemungkinan Supresi Kekebalan Everolimus bahan aktif stent XIENCE Sierra adalah zat imunosupresif Supresi kekebalan tidak terjadi pada kelompok stent S...

Page 195: ...menggunakan kekuatan berlebihan dapat menyebabkan kerusakan atau terlepasnya stent Pertahankan penempatan guide wire di sepanjang lesi dan lepaskan delivery system serta guiding catheter sebagai satu...

Page 196: ...SPIRIT dari Rancangan Percobaan Klinis XIENCE V Sebelum Dipasarkan SPIRIT III RCT SPIRIT IV Registri SPIRIT Small Vessel Percobaan Klinis SPIRIT PRIME Registri Ukuran Inti Registri Lesi Panjang Tipe R...

Page 197: ...3 4 22 655 5 6 18 319 5 1 7 136 2 5 10 399 2 9 3 104 TVR Karena Iskemi Non TL 2 2 54 2416 2 4 29 1195 3 2 21 655 4 7 15 319 5 9 8 136 2 8 11 399 2 9 3 104 Trombosis Stent ARC Pasti Mungkin 0 29 7 2391...

Page 198: ...uk observasi dan dilakukan pada satu kelompok saja untuk mengevaluasi kelangsungan keamanan dan keefektifan XIENCE V EECSS selama penggunaan komersial di dunia nyata di India Tabel 10 2 1 sampai 10 2...

Page 199: ...sis Percobaan Klinis untuk Trombosis Stent Setelah Interupsi Penghentian DAPT Kelompok stent XIENCE terbukti aman dan efektif dalam beberapa percobaan pada pasien standar berisiko rendah maupun pasien...

Page 200: ...15 12 8 1 42 0 056 5F 12 1216 16 1621 84 4 0 38 33 28 23 18 15 12 8 1 42 0 056 5F 12 1216 16 1621 86 F 9 5 2 0 XIENCE Sierra Everolimus 12 65 50 2 3 0 1 0 XIENCE Sierra Everolimus CoCr L 605 XIENCE S...

Page 201: ...fda gov www MHRA gov uk www ema europa eu 2015 5 9 XIENCE Sierra XIENCE SPIRIT XIENCE Sierra CYP3A4 5 10 XIENCE Sierra XIENCE SPIRIT 6 0 6 1 P4503A4 CYP3A4 CsA CYP3A4 XIENCE XIENCE V XIENCE V Sierra...

Page 202: ...0 XIENCE SPIRIT 10 0 XIENCE PRIME XIENCE V EECSS XIENCE Sierra EECSS XIENCE Alpine EECSS XIENCE Xpedition EECSS EECSS XIENCE Sierra EECSS XIENCE Alpine EECSS XIENCE Xpedition EECSS XIENCE PRIME EECSS...

Page 203: ...E V 2458 N TAXUS 1229 N XIENCE V 669 N TAXUS 333 N 2 25 XIENCE V 144 N 401 N 104 N 4 0 2416 97 6 8 1195 81 5 3 655 35 9 7 319 31 8 1 136 11 4 5 399 18 7 7 104 8 5 5 2416 134 7 7 1195 92 8 5 655 56 11...

Page 204: ...5 2348 105 6 0 1158 70 7 1 605 43 11 2 286 32 3 0 133 4 2 0 399 8 4 8 104 5 TLR 6 3 2348 148 7 9 1158 92 8 9 605 54 12 9 286 37 5 3 133 7 2 5 399 10 2 9 104 3 TVR 5 6 2348 132 5 4 1158 63 8 8 605 53 1...

Page 205: ...1 2 6 7522 194 1 71 2627 45 2 97 2562 76 0 9 986 9 1 7 942 16 1 4 7522 108 1 10 2627 29 1 87 2562 48 0 9 986 9 1 7 942 16 6 3 7522 475 3 54 2627 93 4 45 2562 114 1 3 986 13 1 6 942 15 2 2 7505 162 0 8...

Page 206: ...L 800 227 9902 FAX 800 601 8874 Outside USA TEL 951 914 4669 Outside USA FAX 951 914 2531 2017 Abbott Abbott Vascular International BVBA Park Lane Culliganlaan 2B 1831 Diegem BELGIUM TEL 32 2 714 14 1...

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