Устройство для внутрисосудистой тромбэктомии EmboTrap:

देश: बेलारूस

भाषा: रूसी

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

थमां उपलब्ध:

Neuravi Ltd., ИРЛАНДИЯ

वर्ग:

изделия медицинского назначения

द्वारा बनाया गया:

Neuravi Ltd.

प्राधिकरण की तारीख:

2022-03-02

उत्पाद विशेषताएं

CS084 Rev B Attachment 2
Page 1 of 62
INSTRUCTIONS FOR USE
INDICATIONS FOR USE:
The EmboTrap™ II Revascularization Device (the Device) is intended
to be used to restore blood flow in patients experiencing an acute
ischemic stroke due to a large vessel neurovascular occlusion. The
Device is designed for
use in the anterior and posterior neurovasculature in vessels of
diameter 1.5mm to 5mm, such as the internal carotid artery, the M1 and
M2 segments of the middle cerebral artery, the A1 and A2 segments of
the anterior cerebral
artery, the basilar, the posterior cerebral and the vertebral
arteries.
The Device should only be used by physicians trained in
neurointerventional catheterization and the treatment of ischemic
stroke.
DEVICE DESCRIPTION:
The Device is composed of a three dimensional nitinol stent-like
assembly at the distal end of a tapered nitinol shaft as shown in
Figure 1 below. The Device is supplied pre-loaded in an Insertion
Tool.
FIGURE 1: Device Illustration
1. Inner Channel 2. Proximal Markers 3. Outer Cage 4. Distal Markers
5. Distal Mesh
TABLE 1: Device Length Details
(From Figure 1)
RADIOPAQUE FEATURES
CATALOGUE
NUMBER
A
B
C
D
E
F
NUMBER OF RADIOPAQUE
MARKERS
Outer Cage
Diameter
Working
Length
Outer Cage
Length
Overall
Length
Radiopaque
Tip Length
Proximal
Radiopaque
Coil Length
Proximal
Distal
ET-007-521
5MM
21MM
33mm
194cm
4mm
20mm
2
3
ET-007-533
5MM
33MM
44mm
195cm
4mm
20mm
2
3
COMPATIBILITY:
_Microcatheter:_ The Device should be introduced through a size
“18” or larger microcatheter with an internal diameter of 0.021”
or greater and an overall length of not more than 155cm.
_Guide Catheter / Intermediate Catheter:_ The Device should be used in
conjunction with a Neurovascular Guide or Sheath with an internal
diameter of 0.075” or greater. A balloon Guide Catheter may be used.
An Intermediate Catheter may also be used.
CONTRAINDICATIONS:
•
Allergy or hypersensitivity to Nickel-Titanium.
•
Excessive vessel tortuosity that may prevent device delivery.
•
Patients with angiographic