English; Available Models - sorin Perceval S Gebrauchsanweisung

ENGLISH

1. DESCRIPTION
Perceval S is a bioprosthetic valve designed to replace a diseased native or a
malfunctioning prosthetic aortic valve via open heart surgery, with the unique
characteristic of allowing sutureless positioning and anchoring at the implant site.
The choice of materials and configuration ensures the device biocompatibility and
haemocompatibility.
Perceval S prosthesis consists of a tissue component made from bovine pericar-
dium and a self-expandable Nitinol stent, which has the dual role of supporting
the valve and fixing it in place.
Perceval S tissue heart valve is supplied unmounted. Prior to implantation the pros-
thesis diameter is reduced to a suitable size for loading it on the holder. The valve
is then positioned and released in the aortic root, where the stent design and its
ability to apply a radial force to the annulus allows stable anchoring of the device.
2.

AVAILABLE MODELS

The Perceval S aortic model is available in three sizes: size S, size M and size L.
The stent height is 31.0, 33.0 and 35.2 mm, respectively. Each size is suitable for
a range of aortic annuli and sinotubular junction diameters. The characteristics of
the patients aortic root anatomy for each size are described in the table below.
REF
PVS21
PVS23
PVS25
2
SUTURELESS AORTIC HEART VALVE
Instructions for use
AORTIC
ANNULUS
DIAMETER
SIZE
(mm)
S 19-21
M 21-23
L 23-25
Table 1: Patient anatomical characteristics
AORTIC ROOT
HEIGHT
[A]
SINOTUBULAR
(mm)
<21.0
<22.5
<24
JUNCTION
DIAMETER
[≤1.3 A]
(mm)
≤24.7-27.3
≤27.3-29.9
≤29.9-32.5