English
1.0
DEVICE DESCRIPTION
The Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System includes:
• A pre-mounted polymer poly (L-lactide) (PLLA) scaffold coated with a blend of the
antiproliferative drug everolimus and polymer poly (D,L-lactide) (PDLLA) in a 1:1 ratio.
The available dose of everolimus on the scaffold is shown in
Table 1
.
Table 1: Drug Content in Absorb GT1 BVS
Scaffold Diameter
(mm)
Scaffold Length
(mm)
Drug Dose
(μg)
2.5, 3.0
8
76
2.5, 3.0
12
114
2.5, 3.0
18
181
2.5, 3.0
23
228
2.5, 3.0
28
276
3.5
12
135
3.5
18
197
3.5
23
246
3.5
28
308
• Four radiopaque markers located on the end rings of the scaffold mark the scaffold
length prior to deployment and after expansion in the artery because the Absorb GT1
BVS is not visible under fluoroscopy.
• Two radiopaque markers, located underneath the balloon, fluoroscopically mark the
working length of the balloon and the location of the undeployed scaffold of the
scaffold delivery system.
• Absorb GT1 BVS System has a rapid exchange (RX) scaffold delivery system.
• Two proximal delivery system shaft markers (95 cm and 105 cm proximal to the distal
tip) indicate the relative position of the delivery system to the end of brachial or femoral
guiding catheter. Working catheter length is 145 cm.
• A shaft color change denotes the guide wire exit notch.
Table 2:
In Vitro
Device Specifications
Scaffold
Diameter
(mm)
Scaffold
Length
(mm)
* Minimum
Guiding Catheter
Compatibility (ID)
**
In Vitro
Scaffold
Nominal
Pressure
Rated Burst
Pressure –
RBP
Scaffold
Free
Area
(%)
atm
kPa atm kPa
2.5
8
6F (0.070"/1.8 mm)
6
608
16 1621
68
2.5
12
6F (0.070"/1.8 mm)
6
608
16 1621
68
2.5
18
6F (0.070"/1.8 mm)
6
608
16 1621
68
2.5
23
6F (0.070"/1.8 mm)
6
608
16 1621
68
2.5
28
6F (0.070"/1.8 mm)
6
608
16 1621
68
3.0
8
6F (0.070"/1.8 mm)
7
709
16 1621
72
3.0
12
6F (0.070"/1.8 mm)
7
709
16 1621
73
3.0
18
6F (0.070"/1.8 mm)
7
709
16 1621
73
3.0
23
6F (0.070"/1.8 mm)
7
709
16 1621
73
3.0
28
6F (0.070"/1.8 mm)
7
709
16 1621
73
3.5
12
6F (0.070"/1.8 mm)
6
608
16 1621
73
3.5
18
6F (0.070"/1.8 mm)
6
608
16 1621
73
3.5
23
6F (0.070"/1.8 mm)
6
608
16 1621
73
3.5
28
6F (0.070"/1.8 mm)
6
608
16 1621
74
* See individual manufacturer specifications for (F) equivalent.
** Assure full deployment of the scaffold (see section
10.6 Deployment Procedure
).
Deployment pressures should be based on lesion characteristics.
• TagAlert is a non-sterile temperature monitor for the shipping and storage of the
Absorb GT1 BVS System. Before use of this product, check the TagAlert indicator
located through the window in the back of the product box. The indicator should
only show an OK as indicated in the digital display (
Table 3A
). If any other screen is
present (
Table 3B
), do not use product.
Table 3: TagAlert Window Indicator Options, Instructions for Use and Disposal
Window Indicator
Instructions
for Use
Disposal Instructions
A
Use
TagAlert is a battery-
powered device.
Remove TagAlert from
carton and dispose in
accordance with local
regulations.
B
Do not use
2.0
HOW SUPPLIED
Sterile –
This device is E-beam radiation-sterilized. Non-pyrogenic. Do not use if the package
is open or damaged.
This single-use device cannot be reused on another patient, as it is not designed to perform
as intended after the first usage. Changes in mechanical, physical, and / or chemical
characteristics introduced under conditions of repeated use, cleaning, and / or resterilization
may compromise the integrity of the design and / or materials, leading to contamination
due to narrow gaps and / or spaces and diminished safety and / or performance of the
device. Absence of original labeling may lead to misuse and eliminate traceability. Absence
of original packaging may lead to device damage, loss of sterility, and risk of injury to the
patient and / or user.
Contents –
One (1) Absorb GT1 Bioresorbable Vascular Scaffold System; one (1) TagAlert
temperature monitor
Storage –
Store at or below 25°C (77°F); excursions permitted to 30°C (86°F).
3.0 INDICATIONS
The Absorb GT1 BVS is a temporary scaffold indicated for improving coronary luminal
diameter that will eventually resorb and potentially facilitate normalization of vessel function
in patients with ischemic heart disease due to
de novo
native coronary artery lesions. The
treated lesion length should be less than the nominal scaffolding length (8 mm, 12 mm,
18 mm, 23 mm, 28 mm) with reference vessel diameters ≥ 2.0 mm and ≤ 3.8 mm.
4.0 CONTRAINDICATIONS
The Absorb GT1 BVS System is contraindicated for use in:
• Patients in whom antiplatelet and / or anticoagulant therapy is contraindicated
• Patients with a known hypersensitivity or contraindication to aspirin, both heparin
and bivalirudin, clopidogrel, ticlopidine, prasugrel, and ticagrelor, everolimus, poly
(L-lactide), poly (D,L-lactide), or platinum, or with contrast sensitivity, who cannot be
adequately premedicated
5.0 WARNINGS
• The potential long-term benefits of the Absorb coronary device in comparison to the
available therapies are to be confirmed in additional clinical studies.
• This product should not be used in patients who are not likely to comply with the
recommended antiplatelet therapy.
• Judicious selection of patients is necessary, since the use of this device carries the
associated risk of scaffold thrombosis, vascular complications, and / or bleeding
events.
• Oral administration of everolimus in combination with cyclosporine has been
associated with increased serum cholesterol and triglycerides. Therefore, patients
should be monitored for changes in lipid profiles.
• Persons allergic to poly (L-lactide), poly (D,L-lactide), everolimus, or platinum may
suffer an allergic reaction to this implant.
• It is not recommended to treat patients having a lesion with excessive tortuosity
proximal to or within the lesion.
• Devices (i.e., guide sheaths) that decrease the inner diameter of the guide catheter
outside of the Absorb GT1 BVS System minimum guide catheter compatibility
(
Table 2
) must not be used with the Absorb GT1 BVS System. Do not insert a 5-in-6,
or a 6-in-7 guide sheath into a 6F or 7F guiding catheter, as doing so will result in an
inner diameter that is too small for use with the Absorb GT1 BVS System.
• Balloon dilatation of any cells of a deployed Absorb GT1 BVS may cause scaffold
damage.
• Careful selection of the target lesion reference vessel diameter to the scaffold diameter,
and adequate lesion preparation prior to scaffold implantation is recommended to
minimize potential damage to the scaffold during placement. It is not recommended to
treat patients having a lesion that prevents complete inflation of an angioplasty balloon
(example: a severely calcified lesion that has not had adequate lesion preparation), or a
lesion with greater than 40% residual stenosis after predilatation by visual estimation.
6.0 PRECAUTIONS
6.1
Scaffold Handling – Precautions
•
For single use, single insertion only.
Do not resterilize or reuse. Note the product
“Use by” date on the package.
•
Do not remove the scaffold from the delivery system,
as removal may damage the
scaffold and / or lead to scaffold embolization. The scaffold system is intended to
perform together as a system.
• This delivery system should not be used in conjunction with other stents.
• Special care must be taken not to handle or in any way disrupt the scaffold on the
balloon. This is most important during catheter removal from packaging, placement
over the guide wire, and advancement through the rotating hemostatic valve adapter
and guiding catheter hub.
•
Do not manipulate, touch, or handle the scaffold
with your fingers, as this may cause
coating damage, contamination, or dislodgement of the scaffold from the delivery
balloon.
• Use only the appropriate balloon inflation media. Do not use air or any gaseous
medium to inflate the balloon, as this may cause uneven expansion and difficulty in
deployment of the scaffold.
• Implantation of the scaffold should be performed
only
by physicians who have
received appropriate training.
• Scaffold placement should only be performed at hospitals where access to emergency
coronary artery bypass graft surgery (CABG) is available.
• Subsequent restenosis may require repeat dilatation of the arterial segment containing
the scaffold. The long-term outcome following repeat dilatation of endothelialized
scaffolds is unknown at present.
6.2
Scaffold Placement – Precautions
•
Do not prepare or preinflate the delivery system prior to scaffold deployment,
other
than as directed. Use balloon purging technique described in section
10.4.4 Delivery
System Preparation.
• Size the reference target lesion diameter appropriately to avoid overexpanding the
scaffold to ensure adequate scaffold apposition. This will reduce the risk of causing
scaffold damage.
• When introducing the delivery system into the vessel, do not induce negative pressure
on the delivery system. This may cause dislodgement of the scaffold from the balloon.
• Do not torque the catheter more than one (1) full turn.
• Use caution when advancing the Absorb GT1 BVS across the lesion. Multiple attempts
to cross a lesion may lead to scaffold damage or dislodgement.
• Implanting a scaffold may lead to dissection of the vessel distal and / or proximal
to the scaffold and may cause acute closure of the vessel, requiring additional
intervention (CABG, further dilatation, placement of additional scaffolds, or other).
• Do not expand the scaffold if it is not properly positioned in the vessel. (See section
6.4 Scaffold / System Removal – Precautions.
)
• When treating multiple lesions within the same vessel, scaffold / stent the distal lesion
prior to scaffolding the proximal lesion. Scaffolding / stenting in this order obviates
the need to cross the proximal scaffold in placement of the distal scaffold / stent, and
reduces the chance of damaging or dislodging the proximal scaffold.
•
Avoid scaffolding across any side branches ≥ 2.0 mm in diameter.
• The inflated balloon diameter of the system used to deploy the scaffold should
approximate the diameter of the vessel. To ensure full expansion of the scaffold, the
balloon should be inflated to a minimum of nominal pressure.
•
Do not exceed the Rated Burst Pressure (RBP) as indicated on the product label.
Monitor balloon pressures during inflation. Use of pressures higher than specified on
the product label may result in a ruptured balloon, with possible intimal damage and
dissection.
Absorb GT1
Bioresorbable Vascular Scaffold System
INFORMATION FOR PRESCRIBERS
Table of Contents
1.0 DEVICE DESCRIPTION
Table 1: Drug Content in Absorb GT1 BVS
Table 2:
In Vitro
Device Specifications
Table 3: TagAlert Window Indicator Options, Instructions for Use and Disposal
2.0 HOW SUPPLIED
3.0 INDICATIONS
4.0 CONTRAINDICATIONS
5.0 WARNINGS
6.0 PRECAUTIONS
6.1 Scaffold Handling – Precautions
6.2 Scaffold Placement – Precautions
6.3 Use in Conjunction with Other Procedures
6.4 Scaffold / System Removal – Precautions
6.5 Post Implant – Precautions
6.6 MRI Statement
6.7 Drug Interactions
6.8 Pregnancy
7.0 ADVERSE EVENTS
7.1 Observed Adverse Events
7.2 Potential Adverse Events
8.0 CLINICAL INVESTIGATIONS OF ABSORB BVS SYSTEM
8.1 ABSORB Clinical Trial
8.2 ABSORB Cohort A
8.2.1 Methodology and Current Status
8.2.2 Clinical Outcome at 5 Years
Table 4: Clinical Outcome at 5 Years
8.2.3 Angiographic, IVUS, and OCT Outcomes at 180 Days and 2 Years
8.2.4 Vasomotor Function Results at 2 Years
Figure 1: Results of Acetylcholine and Methergine Testing in Proximal,
Scaffolded, and Distal Segments
8.2.5 Discussion
8.3 ABSORB Cohort B
8.3.1 Methodology and Current Status
8.3.2 Clinical Outcomes for Full Cohort B
Table 5: Hierarchical Clinical Outcomes for Cohort B (ITT Population)
8.3.3 Angiographic, IVUS, and OCT Outcomes at 180 Days, 1, 2, and 3 Years
8.3.4 Discussion
8.4 ABSORB EXTEND
8.4.1 Methodology and Current Status
8.4.2 Summary of Clinical Results out to 1 year (Interim Data Cutoff)
Table 6: ABSORB EXTEND Subject Counts of Ischemia-driven Adverse
Events through 393 Days (All Subjects Registered Population)
8.4.3 Summary of Clinical Results out to 2 years (Interim Data Cutoff)
Table 7: ABSORB EXTEND Subject Counts of Ischemia-driven
Adverse Events through 758 Days (250 Subjects Registered
Population)
8.5 Propensity Score Adjusted Analysis of Absorb BVS System and XIENCE V
8.5.1 6-month Propensity Analysis
Table 8: MACE at 6 Months from the IPSW-Adjusted Data
Table 9: Angiographic Outcomes at 6 Months from the IPSW-Adjusted
Data
8.5.2 1-year Propensity Analysis
Table 10: Clinical Outcomes at 1 Year from the IPSW-Adjusted Cohorts
8.5.3 2-year Propensity Analysis
Table 11: Clinical Outcomes at 2 Years from the IPSW-Adjusted
Cohorts
8.6 ABSORB II RCT
8.6.1 Study Design
8.6.2 Summary of Clinical Outcome Data
Table 12: Clinical Outcome through 1 Year
8.7 Benefit of the Absorb Bioresorbable Scaffold Technology
9.0 PATIENT SELECTION AND TREATMENT
9.1 Individualization of Treatment
10.0 CLINICIAN USE INFORMATION
10.1 Inspection Prior to Use
10.2 Materials Required
10.3 Vessel and Lesion Selection
Table 13: Target Vessel Diameter Ranges and Absorb GT1 BVS Diameter to be
Used (Quantitative Imaging)
10.4 Preparation
10.4.1 Packaging Removal
10.4.2 Dual Layer Sheath Removal
10.4.3 Guide Wire Lumen Flush
10.4.4 Delivery System Preparation
10.5 Delivery Procedure
10.6 Deployment Procedure
10.7 Further Expansion of the Deployed Scaffold
10.8 Removal Procedure
11.0 TRADEMARKS
EL2103340 (4/24/15)
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RELEASED
RELEASED
Printed on : 04/29/2015
