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WATCHMAN FLX
1 2 F
Left Atrial Appendage Closure Device
with Delivery System
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
REUSE WARNING
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is
damaged. If damage is found, call your Boston Scientific representative.
For single use only. Do not reuse, reprocess, or resterilize. Reuse, reprocessing, or resterilization
may compromise the structural integrity of the device and/or lead to device failure which, in
turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may
also create a risk of contamination of the device and/or cause patient infection or cross-infection,
including, but not limited to, the transmission of infectious disease(s) from one patient to
another. Contamination of the device may lead to injury, illness, or death of the patient.
DEVICE DESCRIPTION
The WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Technology consists of an
Access System (Access Sheath and Dilator) and Delivery System (Delivery Catheter and Closure
Device). The Access System and Delivery System permit Closure Device placement in the left
atrial appendage (LAA) via femoral venous access and interatrial septum crossing into the left
atrium. The WATCHMAN FLX Device is a self-expanding nitinol (nickel-titanium alloy) structure
with a polyethylene terephthalate (PET) porous membrane on the proximal face. The Closure
Device is constrained within the Delivery System until deployment in the LAA. The WATCHMAN
Closure Device is compatible with all WATCHMAN Access Systems (Access Sheath and Dilator).
The Closure Device is available in 5 sizes from 20 mm to 35 mm. Appropriate Closure Device
sizing is determined by LAA measurements using echocardiographic imaging guidance.
Note: Clinical trial demonstrating safety and effectiveness of the WATCHMAN LAA Closure
Technology (Access System and Delivery System) required the use of transesophageal
echocardiography (TEE) during screening, implantation, and follow-up.
The WATCHMAN FLX Device is permanently implanted at or slightly distal to the ostium
(opening) of the LAA to trap potential emboli before they exit the LAA. The placement
procedure can be done under local or general anesthesia in a hospital cardiac catheterization
or electrophysiology laboratory setting.
Contents
Quantity
Description
1
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System
Materials
The WATCHMAN FLX Left Atrial Appendage (LAA) Closure Device is a self-expanding nitinol
(nickel-titanium alloy) structure with a polyethylene terephthalate (PET) porous membrane
on the proximal face.Materials and material amounts in the Closure Device are listed in Table 1
below. Materials are the same for all Closure Devices, but the amounts listed represent the
35 mm Closure Device, which contains the highest amount of each material.
Table 1. Closure Device Materials
Material
Titanium Dioxide
Polyethylene terephthalate (PET)
Nickel-titanium alloy (Nitinol)
Titanium grade 2
The WATCHMAN FLX Delivery Catheter includes a stainless steel part which contacts
patient blood during the WATCHMAN FLX procedure and which may contain cobalt
(CAS No. 7440-48-4; EC No. 231-158-0; defined as CMR 1B) in a concentration above 0.1 %
weight by weight. This material is contained in a concentration above 0.1 % weight by weight
only in the Delivery Catheter and not the Closure Device. Current scientific evidence supports
that medical devices manufactured from stainless steel alloys containing cobalt do not cause
an increased risk of cancer or adverse reproductive effects.
38
MB Drawing 50573138
™
Amount(s)
0.000 4 g
0.094 g
0.328 g
0.031 g
User Information
Intended Users of the WATCHMAN FLX Device are interventional cardiologists and/or
electrophysiologists who are trained in percutaneous and transseptal procedures and who
have completed the WATCHMAN FLX Physician Training program. The WATCHMAN FLX
Physician Training program is a one-time training program; no re-training is required.
Implantation of the WATCHMAN FLX Device should only be performed by these Intended Users.
INTENDED USE
WATCHMAN FLX is intended for percutaneous, transcatheter closure of the left atrial appendage.
INDICATIONS FOR USE
The WATCHMAN FLX LAA Closure Technology is intended to prevent thrombus embolization
from the left atrial appendage and reduce the risk of life-threatening bleeding events in
patients with non-valvular atrial fibrillation who are eligible for anticoagulation therapy or
who have a contraindication to anticoagulation therapy.
Clinical Benefit Statement
The clinical benefit of the WATCHMAN LAA Closure Technology is to decrease the risk of stroke
by preventing thrombus embolization from the left atrial appendage and decrease the risk
of major bleeding events by reducing the need for long-term blood thinners in patients with
non-valvular atrial fibrillation.
Summary of Safety and Clinical Performance
For customers in the European Union, use the device name found in the labeling to search for
the device's Summary of Safety and Clinical Performance, which is available on the European
database on medical devices (EUDAMED) website: (https://ec.europa.eu/tools/eudamed).
CONTRAINDICATIONS
Do not use the WATCHMAN FLX Device if:
• Intracardiac thrombus is present.
• An atrial septal defect repair or closure device is present.
• A patent foramen ovale repair or closure device is present.
• The LAA anatomy will not accommodate a Closure Device (see Step 7).
• The patient has a known hypersensitivity to any portion of the device material or
the individual components (see Device Description section) such that the use of the
WATCHMAN FLX Device is contraindicated.
• Any of the customary contraindications for other percutaneous catheterization procedure
(e.g., patient size too small to accommodate TEE probe or required catheters) or
conditions (e.g., active infection, bleeding disorder) are present.
• There are contraindications to the use of aspirin or P2Y
WARNINGS
Implantation of the WATCHMAN FLX Device should only be performed by interventional
cardiologists and/or electrophysiologists who are trained in percutaneous and transseptal
procedures and who have completed the WATCHMAN Physician Training program.
• For single use only. Do not reuse, reprocess, or resterilize. Reuse, reprocessing, or
resterilization may compromise the structural integrity of the Closure Device and/or
lead to Closure Device failure which, in turn, may result in patient injury, illness, or death.
Reuse, reprocessing, or resterilization may also create a risk of contamination of the
Closure Device and/or cause patient infection or cross-infection, including, but not limited
to, the transmission of infectious disease(s) from one patient to another. Contamination
of the Closure Device may lead to injury, illness, or death of the patient.
• Careful consideration should be given to use of the Closure Device in pregnant and/or
breastfeeding women due to the risk of significant exposure to x-rays and the possible
use of anticoagulation medication.
• The WATCHMAN FLX LAA Closure Technology has not been studied in patients under the
age of 18.
• Device selection should be based on accurate LAA measurements obtained using
imaging guidance in multiple views to avoid improper Closure Device sizing.
• Do not release (i.e., unscrew) the WATCHMAN FLX from the core wire unless all release
criteria (Step 15) are satisfied to avoid suboptimal results.
• The nickel contained in this product may cause allergic reaction in individuals with nickel
sensitivity. Prior to implantation, patients should be counseled on the materials contained
in the device, as well as potential for allergy/hypersensitivity to these materials.
• The potential for Closure Device embolization exists with cardioversion < 30 days
following Closure Device implantation; verify Closure Device position after cardioversion
during this period.
• Appropriate post-procedure drug therapy should be followed. See Post-Procedure
Information section for further detail.
• Do not use if the temperature exposure indicator dot is red, indicating Closure Device
expansion may have been compromised.
• Do not use if the temperature exposure indicator dot is missing.
3
12
inhibitor.
Black (K) ∆E ≤5.0
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