Product and functional description of the pfm Nit-Occlud VSD Spiral System

  

The Nit-Occlud VSD Spiral System consists of two main components: the Spiral (Pic.1) and the Application System incl. introducer sheath with handgrip (Pic.4). The components are described hereafter:
 
Pic.1: Nit-Occlud VSD Spiral
  
Pic.2: For comparison purposes:
Nit-Occlud Spiral
 

1. Spiral

The spiral is made out of a Nitinol wire. It has primary and secondary windings forming a double disc shape. In the inner lumen of the primary windings an inner core wire also made from Nitinol is placed which reinforces the secondary windings.

The design is very similar to the Nit-Occlud PDA device (see Pic. 2).
The available spiral sizes are:  10x6; 12x6; 14x8 [mm x mm]

In order to achieve a quicker thrombogenicity, and by this a shorter closing period, synthetic fibers are knotted to the windings. (Pic. 3)		  
       
     
 

Pic.3: Configurated Spiral

    
     
 

2. Application System incl. Introducer Sheath with Hand Grip

  
       
 
 
 
Pic.4
  
     
 

The application system consists of several components: a 6F PFTE introducer sheath with Y-Adapter, a disposable handle, a distally tapered core wire made of Nitinol, a stainless steel fixation wire, a stainless steel pusher, a one-hand introducing aid.

The spiral is delivered in a straightened status in the application system.

The complete device is single packed in a blister, and a sterile pouch. It is sterilized by 100% Ethyleneoxide. The device is for single use only, and has to be stored accord. to the storage conditions indicated on the label until its usage.

  
     
 

3. Intended Function

The intended function of the Nit-Occlud VSD System is to introduce the spiral by transcatheter technique to the region of interest (the Ventricular Septum Defect).

The radio-opaque tip of the introducer sheath is placed under echocardiographical and angiographical guidance from the right venous side through the VSD into the left ventrical. When the right position is reached the spiral is pushed outside the introducer sheath by using the one-hand aid. Doing this the spiral configurates itself out of the straightened shape because of the memory effect of the Nitinol. As soon as the correct position and configuration of the spiral is confirmed by X-ray imaging, it is released from the application system, and the complete application system is retrieved.