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Clinical Summary

The AMPLATZER™ Septal Occluder was evaluated in a multi-center, non-randomized, pivotal
study comparing the device to surgical closure of atrial septal defects (ASDs); 423 patients
received 433 devices with a total device exposure of 911.5 years. Individual patient exposure to
the device averaged 25.6 months (ranging from 0 to 38.9).
A Registry group was also studied to evaluate the device in patients with other conditions
appropriate for device closure. Forty-eight (48) patients with Fenestrated Fontan (communication
in the baffle with at least 5 mm distance from the free atrial wall and central venous pressure less
than 15 mm Hg) were enrolled in the study.

Deaths

There was one non-device or procedure-related death reported in the pivotal study, and no deaths
were reported in the Fenestrated Fontan Registry Group.

Observed Adverse Events

Pivotal Clinical Study

Table 1. Adverse Events – Pivotal Study

AMPLATZER™

Patients

Surgical

Control

Patients

p-value

Major Adverse Events

Cardiac arrythmia requiring major treatment

2/442 (0.5%)

0/154 (0.0%)

1.00

Device embolization with surgical removal

3/442 (0.7%)

0/154 (0.0%)

0.57

Device embolization with percutaneous removal

1/442 (0.2%)

0/154 (0.0%)

1.00

Delivery system failure

1/442 (0.2%)

0/154 (0.0%)

1.00

Pericardial effusion with tamponade

0/442 (0.0%)

3/154 (1.9%)

0.017

Pulmonary edema

0/442 (0.0%)

1/154 (0.6%)

0.26

Repeat surgery

0/442 (0.0%)

2/154 (1.3%)

0.066

Surgical wound adverse events

0/442 (0.0%)

2/154 (1.3%)

0.066

Total Major Adverse Events (Patients)

7/442 (1.6%)

8/154 (5.2%)

0.030

Minor Adverse Events

Anemia

0/442 (0.0%)

1/154 (0.6%)

0.26

Allergic reaction (drug)

2/442 (0.5%)

0/154 (0.0%)

1.00

Atelectasis

0/442 (0.0%)

1/154 (0.6%)

0.26

Cardiac arrythmias minor treatment

15/442 (3.4%)

9/154 (5.8%)

0.23

Device embolization with percutaneous removal

1/442 (0.2%)

0/154 (0.0%)

1.00

Extremity tingling/numbness

1/442 (0.2%)

0/154 (0.0%)

1.00

Headaches/possible TIA

2/442 (0.5%)

0/154 (0.0%)

1.00

Delivery system failure

2/442 (0.5%)

0/154 (0.0%)

1.00

Pericardiotomy syndrome

0/442 (0.0%)

2/154 (1.3%)

0.066

Pericardial effusion

0/442 (0.0%)

6/154 (3.9%)

<0.001

Pleural effusion

0/442 (0.0%)

1/154 (0.6%)

0.26

Pneumothorax

0/442 (0.0%)

3/154 (1.9%)

0.017

Staph infection

0/442 (0.0%)

1/154 (0.6%)

0.26

Surgical wound adverse events

0/442 (0.0%)

1/154 (0.6%)

0.26

100092311_ASD.book Page 5 Monday, January 6, 2014 11:00 AM

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Содержание Amplatzer

Страница 1: ...ros okliuderis Naudojimo instrukcija sq Okludues septal Udhëzime për përdorim el Συσκευή απόφραξης διαφράγματος Οδηγίες χρήσης lv Starpsienas Nosprostotājs Lietošanas instrukcija sr Septalni okluder Uputstvo za upotrebu es Oclusor septal Instrucciones de uso nl Septale occluder Gebruiksaanwijzing sv Anordning för slutning av septum Bruksanvisning et Vaheseina sulgur Kasutusjuhend no Septal lukkean...

Страница 2: ...atsparus MR Drošs lietošanai ar MR noteiktos apstākļos MR veilig onder bepaalde voorwaarden MR sikker under visse betingelser Warunkowe użycie z MR Condicional para RM Acceptat MR în anumite condiţii Условно пригодно для использования в МР окружении Podmienky vystavenia MR Pogojna uporaba z magnetno resonanco MR Kushtëzimi nga MR ja Uslovno bezbedno u MR okruženju MR säker under vissa betingelser ...

Страница 3: ...als de verpakking is beschadigd Må ikke brukes hvis pakken er skadet Nie używać jeżeli opakowanie jest uszkodzone Não usar se a embalagem estiver danificada Nu utilizaţi dacă ambalajul este deteriorat Не использовать если упаковка повреждена Nepoužívajte ak je obal poškodený Ne uporabljajte če je embalaža poškodovana Mos e përdorni nëse është dëmtuar ambalazhi Ne koristiti ako je pakovanje oštećen...

Страница 4: ...다 Federalinis įstatymas JAV leidžia pardavinėti šiuos įtaisus tik gydytojams ar tinkamai licencijuotiems praktikams arba jų nurodymu Saskaņā ar ASV federālo likumu šo ierīci drīkst pārdot tikai ārstiem un atbilstoši licencētiem medicīnas darbiniekiem vai abu minēto kategoriju pilnvarotām personām Volgens de Amerikaanse wetgeving mag dit hulpmiddel alleen door of op voorschrift van een arts of gedi...

Страница 5: ...oni per l uso 102 ko 사용 설명서 109 lt Naudojimo instrukcija 115 lv Lietošanas instrukcija 122 nl Gebruiksaanwijzing 129 no Bruksanvisning 136 pl Instrukcja użytkowania 143 pt Instruções de Utilização 151 ro Instrucţiuni pentru utilizare 158 ru Инструкции по применению 165 sk Návod na použitie 173 sl Navodila za uporabo 180 sq Udhëzime për përdorim 187 sr Uputstvo za upotrebu 194 sv Bruksanvisning 201...

Страница 6: ...ndications and Usage The AMPLATZER Septal Occluder is a percutaneous transcatheter atrial septal defect closure device intended for the occlusion of atrial septal defects ASDs in secundum position or patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial ...

Страница 7: ...ient data including inadequate echocardiographic information about the cases already reported to determine etiology of erosion Do not select a device size larger than 1 5 times the ASD diameter measured by echocardiography before balloon sizing Do not release the device from the delivery cable if the device does not conform to its original configuration or if the device position is unstable or if ...

Страница 8: ...20 G cm or less Maximum MR system reported whole body averaged specific absorption rate SAR of 3 W kg for 15 minutes of scanning During testing the device produced a clinically non significant temperature rise at a maximum MR system reported whole body averaged specific absorption rate SAR of 3 W kg for 15 minutes of scanning in a 3 tesla MR system using a transmit receive body coil MR image quali...

Страница 9: ...t block hematoma pseudoaneurysm including blood loss requiring transfusion hemolysis hypertension hypotension infection myocardial infarction perforation pericardial effusion peripheral embolism peripheral pulse loss phrenic nerve injury pleural effusion residual shunt stroke transient ischemic attack thromboembolic event thrombus formation embolization tissue trauma damage valve damage valvular i...

Страница 10: ...ent 2 442 0 5 0 154 0 0 1 00 Device embolization with surgical removal 3 442 0 7 0 154 0 0 0 57 Device embolization with percutaneous removal 1 442 0 2 0 154 0 0 1 00 Delivery system failure 1 442 0 2 0 154 0 0 1 00 Pericardial effusion with tamponade 0 442 0 0 3 154 1 9 0 017 Pulmonary edema 0 442 0 0 1 154 0 6 0 26 Repeat surgery 0 442 0 0 2 154 1 3 0 066 Surgical wound adverse events 0 442 0 0 ...

Страница 11: ...um primum or sinus venosus atrial septal defects Partial anomalous pulmonary venous drainage Pulmonary vascular resistance above 7 Woods units or a right to left shunt at the atrial level with a peripheral arterial saturation less than 94 Patients with recent myocardial infarction unstable angina and decompensated congestive heart failure Patient with right and or left ventricular decompensation w...

Страница 12: ...line Demographics Variable AMPLATZER Patients Surgical Control Patients p value Age years Mean s d N 18 1 19 3 442 5 9 6 2 154 0 001 range 0 6 82 0 0 6 38 2 Gender Female 299 442 67 6 94 154 61 0 0 14 Male 143 442 32 4 60 154 39 0 Height cm Mean s d N 134 6 32 0 440 105 5 26 9 151 0 001 range 58 188 60 178 Weight kg Mean s d N 42 3 27 3 440 20 6 15 2 153 0 001 range 6 3 130 4 8 78 4 Medical Histor...

Страница 13: ...monary bypass aortic cross clamp and right atriotomy If the defect is small primary repair by suturing the defect is feasible however if the defect is large then patch closure is the preferred method Different surgeons use different material for the patch Most surgeons use pericardium however some surgeons use GORE TEX to repair the ASD At the end of the operation the surgeon inserts chest tubes t...

Страница 14: ...ar access site adverse events retroperitoneal hematoma surgical wound adverse events other procedural adverse events pericardial effusion requiring medical management evidence of device associated thrombus formation without embolization with or without treatment and marker band embolization without known sequelae Table 5 Principal Effectiveness and Safety Results Pivotal Study AMPLATZER Patientsa ...

Страница 15: ...49 4 7 0 086 0 008 Minor Adverse Events 12 months 16 328 4 9 29 149 19 5 0 221 0 085 12 month Composite Success K M 0 930 0 944 0 055 0 027 Survival at 30 days K M 0 933 0 954 0 059 0 017 Survival at 180 days K M 0 930 0 954 0 062 0 014 Table 7 Principal Efficacy Results Fenestrated Fontan AMPLATZER Patients Upper 95 Confidence Bound Technical Success 46 48 95 8 0 875 Procedure Success 46 46 100 0...

Страница 16: ...e or impingement on important surrounding cardiac structures Use echocardiographic measurements and an AMPLATZER Sizing Balloon II to determine the diameter of the defect Refer to the instructions for use included with the AMPLATZER Sizing Balloon II for more information Note If balloon sizing is performed in addition to echocardiographic measurements a stop flow technique should be used 6 Insert ...

Страница 17: ...the 2 components 19 Advance the delivery cable and device through the delivery sheath until the device reaches the tip of the delivery sheath Do not rotate the delivery cable CAUTION Do not advance the delivery cable and device if resistance is felt 20 Use angiography and echocardiography for guidance Hold the delivery cable in place while retracting the delivery sheath to deploy the left atrial d...

Страница 18: ...ion of the physician Go to www amplatzer com tempIDcard to print the temporary patient identification card Complete this card and give it to the patient If the patient would like to receive a permanent patient identification card complete the implant registration form and send the completed form to AGA Medical Disposal The carton and instructions for use are recyclable Dispose of all packaging mat...

Страница 19: ...at the buyer s expense returns the goods within the Warranty Period to SJM to the address below and after SJM confirms that the goods are defective SJM Amplatzer Products Product Surveillance Lab 14901 DeVeau Place Minnetonka MN 55345 2126 USA Tel 1 651 756 5833 To the maximum extent permitted by law if a mandatory term is implied by law or a mandatory consumer guarantee applies to the goods and t...

Страница 20: ...ed müüakse eraldi Laitteen ja sisäänviejäjärjestelmän mitat myydään erikseen Dimensions du dispositif et du système de pose vendus séparément Dimenzije umetka i uvodnog sustava prodaje se zasebno Az eszköz és a külön kapható bevezetőrendszer méretei Dimensioni del dispositivo e del sistema di introduzione venduti separatamente 기기 및 전달 시스템 치수 별매 Įtaiso ir įvedimo sistemos matmenys parduodama atskir...

Страница 21: ...63 80 9 ASD 028 28 42 38 4 9 DEL 10F 45 80 10 3 35 0 132 4 01 0 158 80 9 ASD 030 30 44 40 4 9 DEL 10F 45 100 10 3 35 0 132 4 01 0 158 100 9 ASD 032 32 46 42 4 9 ITV12F45 80 12 3 99 0 157 4 80 0 189 80 9 DEL 10F 45 80 10 3 35 0 132 4 01 0 158 80 9 DEL 10F 45 100 10 3 35 0 132 4 01 0 158 100 9 ASD 034 34 50 44 4 9 ITV12F45 80 12 3 99 0 157 4 80 0 189 80 9 DEL 12F 45 80 12 4 01 0 158 4 72 0 186 80 9 ...

Страница 22: ...l forgalomba Non disponibile in tutti i mercati 일부 국가에는 제공되지 않음 Prekiaujama ne visose rinkose Nav pieejams visos tirgos Niet in alle markten verkrijgbaar Ikke tilgjengelig i alle markeder Dostępne wyłącznie w wybranych krajach Não se encontra disponível em todos os mercados Nu este disponibil în unele ţări Доступно не во всех точках продажи Nie sú dostupné na všetkých trhoch Ni na voljo na vseh tr...

Страница 23: ...F1 D C F2 F G E H I J A B 100092311_ASD book Page 232 Monday January 6 2014 11 00 AM ...

Страница 24: ...dical para los que se han concedido patentes o cuyas patentes están pendientes en los EE UU y u otros países se encuentran enumerados en www amplatzer com patents Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL and the nine squares symbol are trademarks and services marks of St Jude Medical Inc and its relat...

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