Изделия для эндоваскулярной хирургии: система саморасширяющегося стента для сонных артерий Protégé™ RX, конический тип, номер модели:

Страна: Беларусь

Язык: русский

Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Доступна с:

Ev3, Inc., СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

класс:

изделия медицинского назначения

Производитель:

Ev3

Дата Авторизация:

2023-01-03

Характеристики продукта

510599-001 Rev. B
ENGLISH
PROTÉGÉ™ RX
Self-expanding Peripheral and Carotid Stent System
INSTRUCTIONS FOR USE
1.
DEVICE DESCRIPTION
The Protégé™ Rx self-expanding peripheral and carotid
stent system is a self-expanding nitinol stent system intended
for permanent implantation. The self-expanding stent is made
of a nickel titanium alloy (nitinol) and comes pre-mounted
on a rapid exchange (Rx) delivery system. The stent is cut
from a nitinol tube in an open lattice design and has tantalum
radiopaque markers at the proximal and distal ends of the
stent. After deployment, the stent achieves its predetermined
diameter and exerts a constant, gentle outward force to
establish patency.
The delivery system, as shown in FIGURE 1, is comprised of
an inner shaft and outer sheath, which are locked together
with a tuohy-borst valve (1). The inner shaft terminates
distally in a flexible catheter tip (2) and originates proximally
at the end of the catheter. Two radiopaque markers, one
marker distal (3) and one retainer marker proximal (4) to
the constrained stent (5), are mounted on the inner shaft.
Delivery systems with tapered stents have an additional
radiopaque marker that identifies where the stent diameter
transition begins.
Tapered stents are mounted onto the delivery catheter with
the smallest diameter toward the distal end of the catheter.
The outer sheath connects proximally to the Y-connector
(6). The self-expanding stent is constrained within the space
between the inner shaft and outer sheath. This space is
flushed before the procedure through the side port of the
Y-connector (7).
The catheter is back-loaded on a 0.36 mm (0.014 in) wire
through the distal tip and exits through the Rx port (8).
Stent positioning at the target lesion is achieved before
deployment by using the two radiopaque markers (9 and 10),
which mark the location of the constrained stent. For stent
deployment, turn the tuohy-borst valve counterclockwise to
unlock the outer sheath.
The stent is deployed by retracting the outer sheath by
pulli