Description; Portico™ Valve; Portico™ Transfemoral Delivery System ("Delivery System") - St.Jude Medical PRT-23 Mode D'emploi

DESCRIPTION

The Portico™ transfemoral transcatheter aortic valve implantation system (hereafter described as the transfemoral implantation system) consists of
the Portico™ valve, the Portico™ transfemoral delivery system, and the Portico™ transfemoral/alternative access loading system. The transfemoral
implantation system is designed to facilitate transcatheter valve implantation using transfemoral access methods. See Table 1 for catalog number
information.
Table 1: Transfemoral implantation system components
access Method
Transfemoral
CaUTION: The transfemoral implantation system should only be used by physicians who have undergone training on use of this
product.
Portico™ Valve
The Portico™ valve, Figure 1, is designed to be implanted in the native aortic heart valve without open heart surgery and without concomitant
surgical removal of the failed native valve.
The valve stent is made from nitinol, a nickel-titanium alloy that has self-expanding properties and is radiopaque. The valve cuff is made from porcine
pericardium that is sutured to the stent frame. The cuff provides the sealing area for implantation. The valve orifice is made by suturing three valve
leaflets, each made from a single layer of bovine pericardium, into a tri-leaflet configuration on the stent frame.
The cuff and leaflet pericardial tissue is preserved and crosslinked in glutaraldehyde. Glutaraldehyde, formaldehyde and ethanol are used in the
valve sterilization process.
The valve leaflets and valve cuff are processed using Linx™ anticalcification treatment. The valve is supplied sterile and non-pyrogenic.
Evaluate the patient's cardiac anatomy for the characteristics described in Table 2.
waRNING: Do not implant the valve if the patient's anatomy does not fall within the specified ranges.
Table 2: Patient Anatomical Specifications
Catalog annulus
Number Diameter
PRT-23 19 - 21 mm
PRT-25 21 - 23 mm
PRT-27 23 - 25 mm
Retainer tabs
{
Aortic end
of valve
Figure 1: Portico™ valve
Portico™ Transfemoral Delivery System ("Delivery System")
The Portico™ transfemoral delivery system facilitates Portico™ valve implantation using transfemoral access methods. The delivery system is an
over-the-wire, 0.035" (0.89 mm)-compatible system.
The delivery system design facilitates gradual, controlled deployment of the valve. The valve is deployed annulus end first, from the distal end of
the delivery system. If needed, the valve may be re-sheathed and repositioned up to two times, provided the valve has not been more than 80%
deployed. See Table 3 for delivery system specifications.
Table 3: Portico™ Delivery System Specifications
Delivery System Outer Diameter at
Distal End
PRT-DS-TF-18F 18F (6.0 mm)
PRT-DS-TF-19F 19F (6.3 mm)
Portico™ Valve Catalog Numbers
PRT-23 (23 mm) or PRT-25 (25 mm)
PRT-27 (27 mm)
ascending aorta
Diameter
26 - 36 mm
28 - 38 mm
30 - 40 mm
Stent
}
Annulus end
of valve
Minimum Vessel Diameter
Requirement
≥ 6.0 mm
≥ 6.5 mm
Portico™ Delivery System Portico™ Loading System
Catalog Number Catalog Number
PRT-DS-TF-18F PRT-LS-TF/ALT-18F
PRT-DS-TF-19F PRT-LS-TF/ALT-19F
2