Клапан аортальный эндоваскулярно имплантируемый: система клапанная сердечная транскатетерная Myval™

Страна: Беларусь

Язык: русский

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

Доступна с:

Meril Life Sciences Pvt. Ltd., ИНДИЯ

класс:

изделия медицинского назначения

Производитель:

Meril Life Sciences Pvt. Ltd.

Дата Авторизация:

2021-10-25

Характеристики продукта

1.0
DEVICE DESCRIPTION
TM
Myval
Transcatheter
Heart
Valve
System
comprises
of
following
components:
TM
l
A balloon expandable Myval
Transcatheter Heart Valve consisting of a)
a frame of cobalt alloy MP35N, b) a tri-leaflet valve made from fixed
bovine pericardium tissue and c) inner and outer fabric covers.
TM
l
Navigator
Transcatheter Heart Valve Delivery System suitable for
TM
implantation of Myval
by balloon expansion. The distal portion of its
shaft can be flexed to match curvature of aortic arch. It includes an
atraumatic tapered tip at its distal end. Radiopaque markers are
provided within the balloon for guidance under fluoroscopy.
TM
l
A
Mammoth
Balloon
Dilatation
Catheter
consists
of
a
balloon
(dilatation element). Dual lumens permit simultaneous movement of
guide wire as well as balloon inflation fluid. The proximal end of the
shaft
has a 'Y' luer hub with two ports; one for introducing balloon
inflation
fluid and the second which acts as a guide wire exit port. Radiopaque
markers are provided within the balloon for guidance under fluoroscopy
for positioning the device across the treatment site.
TM
l
Python
Introducer
Sheath
consists
of
a
introducer
tube
with
radiopaque distal tip and equipped with proximal hemostatic valve, two
(2) size matched dilators, two (2) loaders and an extension line with
3
TM
way stopcock. Python Introducer Sheath is intended for insertion of
TM
TAVR related hardware such as Guide wires, Mammoth Balloon
TM
Dilatation
Catheter,
Myval
THV
pre-mounted
on
the
balloon
of
TM
Navigator
in and out of patient's vasculature.
TM
l
Val-de-Crimp
Transcatheter Heart Valve Crimping Tool (Sterile) /
TM
CrocoDial
Transcatheter Heart Valve Crimping Tool (Non-sterile) is a
TM
TM
crimping tool used for crimping Myval
THV on balloon of Navigator
.
1.1
DEVICE COMPONENTS DESCRIPTION
TM
1.1.1
MYVAL TRANSCATHETER HEART VALVE
TM
Myval
THV is offered in diameters – 20mm, 21.5mm, 23mm, 24.5mm,
26mm, 27.5mm and 29mm.
The parameters of these sizes are given in the following table.
REFERENCE/
CATALOG
NUMB