English - Abbott ABSORB BVS Manual De Usuario

ABSORB
Bioresorbable Vascular Scaffold (BVS) System
INFORMATION FOR PRESCRIBERS
Table of Contents
1.0 DEVICE DESCRIPTION
Table 1: Drug Content in ABSORB BVS
Table 2: In vitro Device Specifications
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 3 Years
Table 3: Clinical Outcome at 3 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 Cohort B Group 1 and Full Cohort B
Table 4: Hierarchical Clinical Outcomes for Cohort B (ITT Population)
8.3.3 Angiographic and IVUS Outcomes at 180 days
8.3.4 Discussion
9.0 INDIVIDUALIZATION OF TREATMENT
10.0 CLINICIAN USE INFORMATION
10.1 Vessel and Lesion Selection
10.2 Inspection Prior to Use
10.3 Peel-away Sheath Removal
10.4 Materials Required
10.5 Device Preparation
10.5.1 Guide Wire Lumen Flush
10.5.2 Delivery System Preparation
10.6 Delivery Procedure
10.7 Deployment Procedure
10.8 Removal Procedure
11.0 TRADEMARKS
1.0 DEVICE DESCRIPTION
ABSORB 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 BVS
Scaffold Diameter Scaffold Length
(mm) (mm)
2.5, 3.0 18
3.0 28
• 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 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 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 143 cm.
• A shaft color change denotes the guide wire exit notch.
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English

Table 2: In vitro Device Specifications
Scaffold Diameter Scaffold Length
(mm)
2.5
3.0
3.0
** In vitro Scaffold Nominal
Scaffold Diameter
(mm)
(atm)
2.5 6
3.0 7
3.0 7
* See individual manufacturer specifications for (F) equivalent.
** Assure full deployment of the scaffold (see Clinician Use Information – Deployment
Procedure). Deployment pressures should be based on lesion characteristics.
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 re-sterilization 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 Bioresorbable Vascular Scaffold (BVS) System
Storage – Store at or below 25°C (77°F).
3.0 INDICATIONS
The ABSORB Bioresorbable Vascular Scaffold (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 (18 mm, 28 mm) with reference vessel diameters ≥ 2.0 mm and
≤ 3.3 mm.
4.0 CONTRAINDICATIONS
The ABSORB 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
• Judicious selection of patients is necessary, since the use of this device carries the
associated risk of scaffold thrombosis, thrombosis, vascular complications,
and / or bleeding events.
• It is not recommended to treat patients having a lesion with excessive tortuosity
proximal to or within the lesion.
• Balloon dilatation of any cells of a deployed ABSORB BVS will cause scaffold
damage.
• Do not intentionally torque the catheter.
• 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, or a lesion with greater than 40% residual stenosis after
predilatation by visual estimation.
• 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
Drug Dose
suffer an allergic reaction to this implant.
(μg)
6.0 PRECAUTIONS
160
6.1 Scaffold Handling – Precautions
•
For single use, single insertion only.
235
"Use by" date on the package.
•
Do not remove the scaffold from the delivery system,
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
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
* Minimum Guiding Catheter
(mm) Compatibility (ID)
18 6F (0.070"/1.8 mm)
18 6F (0.070"/1.8 mm)
28 6F (0.070"/1.8 mm)
Rated Burst Pressure –
Scaffold
Pressure RBP
Free Area
(%)
kPa (atm) kPa
608 16 1621 73
709 16 1621 77
709 16 1621 78
Do not resterilize or reuse. Note the product
as removal may damage the
with your fingers, as this may
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
under Delivery System Preparation.
• Size the reference target lesion diameter appropriately to avoid overexpanding the
scaffold to ensure good scaffold apposition. It would 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.
• Use caution when advancing the ABSORB BVS across the lesion. Multiple attempts
to cross a lesion may lead to scaffold damage or dislodgement.
• Scaffolding or stenting of multiple lesions within the same epicardial vessel is not
recommended. However, if it must occur, 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.
• When multiple ABSORB Bioresorbable Vascular Scaffolds and drug-eluting stents
are required, only ABSORB Bioresorbable Vascular Scaffolds or everolimus-eluting
stents must be used. Potential interaction with other drug-eluting stents or coated
stents has not been evaluated and should be avoided.
• The extent of the patient's exposure to drug and polymer is directly related to
the number of scaffolds implanted. A patient can receive up to four ABSORB
Bioresorbable Vascular Scaffolds depending on the number of vessels treated and
the lesion length. Those patients receiving bailout scaffolding will receive additional
drug. The use of multiple ABSORB Bioresorbable Vascular Scaffolds will result in
the patient receiving larger amounts of drug and polymer.
• Do not expand the scaffold if it is not properly positioned in the vessel.
Scaffold / System Removal – Precautions.)
• Avoid scaffolding across any side branches ≥ 2.0 mm in diameter.
• 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.
• 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).
• Postdilatation with a noncompliant balloon is recommended as long as the
postdilated segment is within the allowable expansion limits of the scaffold.
• An unexpanded scaffold may be retracted into the guiding catheter
An unexpanded scaffold should not be reintroduced into the artery once it has been
pulled back into the guiding catheter. Subsequent movement in and out through the
distal end of the guiding catheter should not be performed, as the scaffold may be
damaged or dislodged during retraction back into the guiding catheter. Should any
resistance be felt at any time during withdrawal of the ABSORB BVS System, the
entire system should be removed as a single unit.
• Scaffold retrieval methods (use of additional wires, snares, and / or forceps) may
result in additional trauma to the coronary vasculature and / or the vascular access
site. Complications may include bleeding, hematoma, or pseudoaneurysm.
• In the rare event of acute occlusion following scaffold placement, a bailout implant
may be inserted and deployed within the scaffold such that the ABSORB BVS is
completely covered by the bailout implant. All abrupt closures must be treated as an
emergency per the hospital standard of care.
Note: It is recommended that bailouts be done with a metallic everolimus-eluting
stent of appropriate size.
• The safety and effectiveness of the ABSORB BVS in patients with prior
brachytherapy of the target lesion or the use of brachytherapy for treated
site restenosis in an ABSORB BVS have not been established. Both vascular
brachytherapy and the ABSORB BVS alter arterial remodeling. The combination
between these two treatments has not been established.
6.3 Use in Conjunction with Other Procedures
• The safety and effectiveness have not been established with use of the following
devices: mechanical atherectomy devices (directional atherectomy catheters,
rotational atherectomy catheters) or laser angioplasty catheters in conjunction with
ABSORB BVS implantation.
6.4 Scaffold / System Removal – Precautions
Should any resistance be felt at any time during either lesion access or removal of the delivery
system post scaffold implantation, remove the entire system as a single unit.
When removing the delivery system as a single unit:
• DO NOT retract the delivery system into the guiding catheter.
• Position the proximal balloon marker just distal to the tip of the guiding catheter.
• Advance the guide wire into the coronary anatomy as far distally as safely possible.
• Tighten the rotating hemostatic valve to secure the delivery system to the guiding
catheter; then remove the guiding catheter and delivery system as a single unit.
Failure to follow these steps and / or applying excessive force to the delivery system can
potentially result in loss or damage to the scaffold and / or delivery system components.
If it is necessary to retain guide wire position for subsequent artery / lesion access, leave the
guide wire in place and remove all other system components.
6.5 Post Implant – Precautions
If necessary to cross a newly deployed scaffold with a guide wire, balloon, delivery system, or
imaging catheters, exercise care to avoid disrupting the scaffold geometry.
6.6 MRI Statement
Comparison to metallic stents indicates that the ABSORB BVS, in single and in overlapped
configurations, is MRI safe when scanned under the following conditions:
• Static magnetic field of 3 Tesla or less
• Spatial gradient of 720 gauss/cm or less
• Maximum whole body averaged specific absorption rate (SAR) of 3.0 W/kg for 15
minutes of imaging
6.7 Drug Interactions
Everolimus is extensively metabolized by the cytochrome P4503A4 (CYP3A4) in the gut wall and
liver, and is a substrate for the countertransporter P-glycoprotein. Everolimus has also been shown
to reduce the clearance of some prescription medications when it was administered orally along
with cyclosporine (CsA). Hence, Everolimus, when prescribed as an oral medication may interact
with other medications that include (but are not restricted to) inhibitors and inducers of CYP3A4
(See
one time only.