En Instructions For Use; Nit-Occlud® Lê Vsd; Product Description - PFM Medical Nit-Occlud Le VSD Mode D'emploi

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Instructions for Use

Nit-Occlud® Lê VSD

The Nit-Occlud® Lê VSD coil is a permanent implant for the closure of Ventricular Septal Defects (VSD), introduced into

the ventricles by means of minimally invasive catheter technology. The coil is made of nitinol, a material with shape

memory characteristics, and in its relaxed state it adopts to the form of a pair of cones nested in each other. To acceler-

ate clotting and reduce the closure time, polyester threats are tied to the distal coil surface, with the largest windings.

Nit-Occlud® Lê VSD coils is manufactured/ is available in different sizes, to provide optimum closure for a wide range

of VSDs.

The Nit-Occlud® Lê VSD coil system consists of two main components: the coil itself and a delivery system including

implantation catheter and delivery handle, single-use only:

from left to right:

Nit-Occlud® Lê VSD Coil:

lateral

Y-connector:

Markers:

bp = baseline point

M1 = four windings outside the implantation catheter

M2 = o nly two windings remain within the implantation

catheter

M3 = whole of coil outside implantation catheter

Single-use handle:

frontal

Implantation catheter with fitted coil:

Single hand control:

Delivery system (with markings):

GA053/Rev02_2019-04-18

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