English; Contraindications - Edwards PASCAL Gebrauchsanweisung

English

Edwards PASCAL Transcatheter Valve
Repair System
Instructions for Use
The Edwards PASCAL transcatheter valve repair system includes (herein
referred to as the PASCAL system):
Device Model
10000IS
Implant System
10000ISM
Guide Sheath 10000GS
Stabilizer 10000ST
Table 10000T
* Guide Sheath, Stabilizer and Table are packaged together as reorder
number 10000KIT .
• Implant System
The Implant System consists of the Steerable Catheter (outermost layer),
the Implant Catheter (innermost layer), and the Implant (hereinafter
refers to implants from Model 10000IS and Model 10000ISM) . The
Implant System percutaneously delivers the Implant to the valve via a
femoral vein access using a transvenous approach .
• Implant (Figures 1-3)
The Implant is deployed and secured to the leaflets of the valve, acting as
a filler in the regurgitant orifice . The primary components of the Implant
are the spacer, paddles, and clasps constructed from nitinol and covered
in polyethylene terephthalate . The 10000IS Implant also comprises a
titanium nut and bolt, PEEK bushing, and a silicone seal . The 10000ISM
Implant also comprises a titanium nut, bolt, distal and proximal plate, and
a silicone seal and is a smaller size implant .
The Implant has four main paddle positions: Elongated, Closed,
Leaflet-Capture-Ready, and Leaflet-Captured .
• Steerable Catheter (Figure 4)
The Steerable Catheter has a rotational control knob that actuates the
flexion mechanism to navigate and position the Implant to the target
location . A radiopaque marker band located on the distal portion of the
catheter indicates the end of the flex section .
• Implant Catheter (Figure 4)
The Implant is provided attached to the Implant Catheter by sutures and a
threaded shaft . The Implant Catheter controls the deployment of the
Implant . The three primary controls are the Sliders, the threaded
Actuation Knob, and the Release Knob . The Sliders control the Implant
Clasps (retracting the Sliders raises the Clasps and advancing the Sliders
lowers the Clasps) . The threaded Actuation Knob controls the Implant
Paddles (retracting the Actuation Knob closes the Paddles and advancing
the Actuation Knob opens the Paddles) . The Release Knob controls the
Edwards, Edwards Lifesciences, the stylized E logo, CLASP, and PASCAL are
trademarks of Edwards Lifesciences Corporation . All other trademarks are the
property of their respective owners .
• Guide Sheath (Figure 5)
• Stabilizer (Figure 6)
Reorder Number
10000ISCE
10000ISMCE
10000GSCE*
10000STCE*
• Table (Figure 7)
10000TCE*
• Loader (Figure 8)
1.0
The Edwards PASCAL transcatheter valve repair system is indicated for the
percutaneous reconstruction of an insufficient mitral and/or tricuspid valve
through tissue approximation .
2.0
The PASCAL system is contraindicated in patients with:
• Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
• Presence of an occluded or thrombosed IVC filter that would interfere
• Known hypersensitivity to nitinol (nickel or titanium) or contraindication
• History of bleeding diathesis or coagulopathy or patient who refuses
Additionally, the PASCAL system is contraindicated in mitral patients with
contraindication to transseptal catheterization .
3.0
3.1
For optimal results, the following anatomic patient characteristics should be
considered . The safety and effectiveness of the PASCAL system outside of
these conditions has not been established . Use outside these conditions may
interfere with placement of the Implant or native valve leaflet insertion .
Applicable to mitral and tricuspid patients:
• Evidence of moderate to severe calcification in the grasping area
• Evidence of severe calcification in the annulus or subvalvular apparatus
• Presence of significant cleft or perforation in the grasping area
• Leaflet mobility length < 8 mm
2
release of the Implant from the Implant Catheter . The Implant Catheter is
provided assembled within the Steerable Catheter .
The Guide Sheath set includes a steerable Guide Sheath and Introducer .
The Guide Sheath provides atrial access . It has a hydrophilic coating and a
rotational control knob which actuates the flexion mechanism to position
the Guide Sheath at the target location . The Introducer is compatible with
a 0 . 0 35 inch (0 . 8 9 mm) guidewire .
The Stabilizer grips the nosepiece on the Guide Sheath or the Steerable
Catheter to support and maintain catheter positioning . A push-down
mechanism engages/disengages the catheter to allow repositioning as
needed . The use of the Stabilizer is optional .
The Table is used outside of the sterile field to provide a stable platform
for the Implant System, Guide Sheath, and Stabilizer . The Table is height-
adjustable . The use of the Table is optional .
The Peel Away Loader is used to introduce the Implant and delivery
catheters through the Guide Sheath seals . The Loader is included in the
Implant System and/or Guide Sheath packaging for user convenience .
Indications

Contraindications

with the delivery catheter, or ipsilateral deep vein thrombosis is present
to procedural medications which cannot be adequately
managed medically
blood transfusions
Warnings
Anatomic Considerations