Edwards PASCAL Manual Del Usuario

Edwards PASCAL Transcatheter Valve Repair System
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English
Edwards PASCAL Transcatheter Valve Repair System
Instructions for Use
The Edwards PASCAL transcatheter valve repair system includes the following configurations
(herein referred to as the PASCAL system):
Table 1: Model 10000
Model Number Device
PASCAL Implant
10000IS
System
PASCAL Ace Implant
10000ISM
System
Table 2: Model 15000
Model Number Device
PASCAL Implant
15000IS
System
PASCAL Ace Implant
15000ISM
System
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, Model 10000ISM, Model 15000IS and Model 15000ISM). 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
Edwards, Edwards Lifesciences, the stylized E logo, CLASP, PASCAL, and PASCAL Ace are
trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their
respective owners.
Directory
Compatible Devices
Model Numbers Device
10000GS Guide Sheath
10000ST Stabilizer
20000ST Stabilizer Rail System
10000T Table
Compatible Devices
Model Numbers Device
Guide Sheath
10000GS
Stabilizer Rail
20000ST
System
10000T
Table
and 15000IS Implants also comprise a titanium nut and bolt, PEEK bushing, and a silicone
seal. The 10000ISM and 15000ISM Implants also comprise a titanium nut, bolt, distal and
proximal plate, and a silicone seal and are smaller size implants.
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 release of the Implant from the Implant Catheter. The
Implant Catheter is provided assembled within the Steerable Catheter.
Guide Sheath (Figure 5)
•
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 0.035 inch (0.89 mm) guidewire.
• Stabilizer (Figures 6 and 7)
The Stabilizer is indicated to aid with positioning and stabilization of the PASCAL system
during implantation procedures. The Stabilizer can be attached to the system as needed any
time during the procedure. The use of the Stabilizer is optional.
• Table (Figure 8)
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.
• Loader (Figure 9)
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.
1.0 Indications
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 Contraindications
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 with the delivery
catheter, or ipsilateral deep vein thrombosis is present
• Known hypersensitivity to nitinol (nickel or titanium) or contraindication to procedural
medications which cannot be adequately managed medically
• History of bleeding diathesis or coagulopathy or patient who refuses blood transfusions
Additionally, the PASCAL system is contraindicated in mitral patients with contraindication to
transseptal catheterization.
3.0 Warnings
3.1 Anatomic Considerations
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
Applicable to mitral patients only:
• Flail width > 15 mm and/or flail gap > 10 mm
• Transseptal puncture height < 3.5 cm
• LA diameter ≤ 35 mm
• Presence of two or more significant jets
• Presence of one significant jet in the commissural area
• Mitral valve area (MVA) < 4.0 cm
• LVEDD > 8.0 cm
Applicable to tricuspid patients only:
• Presence of primary non-degenerative tricuspid disease
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