Idiomas disponibles
Idiomas disponibles
INSPIRIS RESILIA Valve
(model 11500A)* Labeled Size
21 mm
23 mm
25 mm
*INSPIRIS RESILIA valve model 11500A sizes 19 - 25 mm incorporate VFit
technology which consists of expandable bands and fluoroscopically
visible size markers designed for potential future valve-in-valve
procedures. Clinical data are not currently available on the INSPIRIS
RESILIA valve Model 11500A valve-in-valve procedure or expansion
feature. The impact of tissue ingrowth on the expansion feature of the
INSPIRIS RESILIA valve has not been assessed.
WARNING: Do not perform stand-alone balloon valvuloplasty
procedures in the INSPIRIS RESILIA valve for the sizes 19 - 25 mm.
This may expand the valve causing incompetence, coronary
embolism or annular rupture.
Note: INSPIRIS RESILIA valve model 11500A sizes 27 - 29 mm do not
incorporate VFit technology and therefore follow the surgical valve
True ID sizing provided in Table 2.
Note: Exact volume required to deploy the THV may vary depending
on the bioprosthesis inner diameter. Factors such as calcification and
pannus tissue growth may not be accurately visualized in imaging
and may reduce the effective inner diameter of the failing
bioprosthesis to a size smaller than the 'True ID' . These factors
should be considered and assessed in order to determine the most
appropriate THV size to achieve nominal THV deployment and
sufficient anchoring. Do not exceed the rated burst pressure. See
inflation parameters in Table 4.
• Edwards COMMANDER Delivery System (Figure 2)
The Edwards COMMANDER delivery system facilitates the placement of
the bioprosthesis. It consists of a Flex Catheter to aid in valve alignment
to the balloon, tracking, and positioning of the valve. The delivery system
includes a tapered tip to facilitate crossing of the valve. The handle
contains a Flex Wheel to control flexing of the Flex Catheter, and a
Balloon Lock and Fine Adjustment Wheel to facilitate valve alignment
and positioning of the valve within the target location. A stylet is
included within the guidewire lumen of the delivery system. The Balloon
Catheter has radiopaque Valve Alignment Markers defining the working
length of the balloon. A radiopaque Center Marker in the balloon is
provided to help with valve positioning. A radiopaque Triple Marker
proximal to the balloon indicates the Flex Catheter position during
deployment.
The inflation parameters for valve deployment are:
Nominal Balloon
Model
Diameter
9610TF20
20 mm
9610TF23
23 mm
9610TF26
26 mm
9610TF29
29 mm
• Qualcrimp Crimping Accessory (Figure 3)
The Qualcrimp crimping accessory is used during THV crimping.
• Loader (Figure 4)
The loader is used to aid insertion of the delivery system into the sheath.
• Edwards Crimper and Crimp Stopper (Figure 5)
The Edwards crimper reduces the diameter of the valve to mount it onto
the delivery system. The crimper is comprised of a housing and a
compression mechanism that is closed with a handle located on the
housing. A 2-piece crimp stopper is used to crimp the valve to its
intended diameter.
• Edwards Sheath
Refer to the sheath instructions for use for device description.
• Inflation Device
THV Size
23 mm or 26 mm
26 mm
29 mm
Table 4
Nominal
Inflation
Rated Burst
Volume
Pressure (RBP)
11 ml
7 atm
17 ml
7 atm
23 ml
7 atm
33 ml
7 atm
An inflation device with locking mechanism is used during valve
deployment.
Note: For proper volume sizing, the delivery system must be used
with the inflation device provided by Edwards Lifesciences.
2.0 Intended Use
The bioprosthesis is intended for use in patients requiring heart valve
replacement. The delivery system and accessories are intended to
facilitate the placement of the bioprosthesis via the transfemoral access
approach.
3.0 Indications
The Edwards SAPIEN 3 Transcatheter Heart Valve system is indicated for
use in patients with a dysfunctional, previously repaired or replaced non-
compliant Right Ventricular Outflow Tract/Pulmonary Valve (RVOT/PV) or
previously implanted valve in the pulmonic position.
4.0 Contraindications
Use of the Edwards SAPIEN 3 THV system is contraindicated in patients
who:
• Cannot tolerate anticoagulation/antiplatelet regimen or who have
active bacterial endocarditis or other active infections.
5.0 Warnings
• The devices are designed, intended, and distributed STERILE for single
use only. Do not resterilize or reuse the devices. There are no data to
support the sterility, nonpyrogenicity, and functionality of the devices
after reprocessing.
• Correct sizing of the THV is essential to minimize the risk of
paravalvular leak, migration, valve embolization and/or RVOT rupture.
• The physician must verify correct orientation of the THV prior to its
implantation.
• Accelerated deterioration of the THV may occur in patients with an
altered calcium metabolism.
• Observation of the pacing lead throughout the procedure is essential
to avoid the potential risk of pacing lead perforation.
• Assessment for coronary compression risk prior to valve implantation is
essential to prevent the risk of severe patient harm.
• The THV must remain hydrated at all times and cannot be exposed to
solutions, antibiotics, chemicals, etc. other than its shipping storage
solution and sterile physiologic saline solution to prevent leaflet
damage that may impact valve functionality. THV leaflets mishandled
or damaged during any part of the procedure will require replacement
of the THV.
• Patients with hypersensitivities to cobalt, nickel, chromium,
molybdenum, titanium, manganese, silicon, bovine tissue, and/or
polymeric materials may have an allergic reaction to these materials.
• Do not use the THV if the tamper evident seal is broken, as sterility may
be compromised.
• Do not use the THV if the temperature indicator has been activated, as
valve function may be compromised.
• Do not use the THV if the expiration date has elapsed, as either sterility
or valve function may be compromised.
• Do not use the THV if the storage solution does not completely cover
the THV or the THV is damaged.
• Do not mishandle the delivery system or use the delivery system and
accessory devices if the packaging sterile barriers and any components
have been opened or damaged, cannot be flushed, or the expiration
date has elapsed.
• Patient injury could occur if the delivery system is not un-flexed prior
to removal.
• Valve recipients should be maintained on anticoagulant/antiplatelet
therapy, except when contraindicated, to minimize the risk of valve
thrombosis or thromboembolic events, as determined by their
physicians. This device has not been tested for use without
anticoagulation.
• The procedure should be conducted under fluoroscopic guidance.
Some fluoroscopically guided procedures are associated with a risk of
radiation injury to the skin. These injuries may be painful, disfiguring,
and long-lasting.
• Patients with pre-existing bioprostheses should be carefully assessed
prior to implantation of the valve to ensure proper valve positioning
and deployment.
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