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CARDIVA VASCADE MVP Manuel D'utilisation page 2

Venous vascular closure system

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  • FRANÇAIS, page 49
VASCADE Family devices are intended for the percutaneous closure of femoral vessel access sites in patients who have undergone
catheter-based procedures.
The VASCADE MVP Venous Vascular Closure System (VVCS) is indicated for patients who require percutaneous closure of femoral
venous access sites and have undergone catheter-based procedures using 6–12F inner diameter procedural sheaths, with single
or multiple access sites in one or both limbs.
Physicians and technicians with experience accessing femoral vessels via introducer sheaths.
Clinical benefits are rapid closure of vascular access sites, which may increase comfort after the procedure and allow patients to
start walking again sooner.
Device
Model
Diameter
VASCADE
800-
6–12F
MVP VVCS
612C
*The Collagen Patch is made of Type I Bovine Collagen delivered in a compressed form. The collagen implant is a biological material compatible with
Each shelf carton contains at minimum:
Multiple single-use devices (quantity per labelling)
Each single-use sterile device is supplied with:
o
One (1) Sterile Clip.
o
One (1) Patient Implant Card to be given to the patient.
o
One (1) Patient Implant Leaflet with instructions on how to fill in the Patient Implant Card.
One (1) printed Instructions for Use.
IFU 5686 AE, 2024-04
Patient Target Group
Technical Specifications
Sheath Size
Sheath
Inner
Max Outer
Length
Diameter
(ID)
(OD)
15F
Magnetic Resonance Imaging (MRI).
Intended Purpose
Intended User
Clinical Benefits
Collagen
Disc
Patch*
Diameter
Length
Up to
7.7 mm
15 mm
12 cm
Contents of Package
Collagen
Device
Dry
Working
Weight
Length
12 mg
15 cm
± 3 mg
Page 2 of 24
Device
Max OD
(with
Collapsed
Disc)
2.1 mm

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