ASD/VSD

Nit-Occlud® ASD-R

Nit-Occlud® ASD-R is knitted from a single nitinol wire without soldering. It consists of two discs, a distal or left one and a proximal or right one. The unique single-layer distal disc reduces the metal used in the left-atrium (LA) by around 50%, thus providing best patients benefit by reducing the thrombo-embolic risk.


Benefits

Unique single-wire knit  Nit-Occlud® ASD-R is knitted from a single Nitinol wire, making protruding
fixation-clamps obsolete and results in a very low profile.

Safe and simple device release  The occluder is pre-mounted, retrievable, easy to position and enables a soft and tension free release.

Patented design  The single-layer left atrial disc reduces the amount of metal used in the LA by around 50% and by this decreasing the thrombo-embolic risk.

Pre-attached and ready to use  Pre-attached to the delivery cable and ready to use. Can be easily connected to pfm medical Nit-Occlud Implantation Sheaths via a Luer connection.

Adaptive flexible design  Optimal compromise between flexibility and strength. The rim of the LA disc is reinforced to facilitate implantation and to avoid pull through.

Accelerated endothelialisation  The polyester membrane facing the LA promotes accelerated endothelialisation.

Details

  • Flexible and adaptive design
  • Single-wire knit
  • No need for protruding clamps to fixe loose wire ends
  • Very low-profile
  • Reduction metal of around 50% in the LA
  • LA polyester face accelerating endothelialisation
  • Pre-mounted systems and simple to release
  • Easy to reposition and to retrieve
  • Radiopaque
  • MR conditional

Knowledge

The Nit-Occlud® ASD-R occlusion system has been developed for the transcatheter occlusion of the atrial septal defect (ASD). 

Nit-Occlud® ASD-R is the latest member of the growing pfm medical occluder family and is also manufactured from a single nitinol wire, resulting in a very low profile. The occluder consists of two discs with polyester membranes.

Manufacturer

pfm medical ag 

Wankelstraße 60 

50996 Köln, Germany

Ordering Information

Screenshot 2015-10-30 14.08.08


Downloads

Brochure Nit-Occlud® ASD-R

IFU Nit-Occlud® ASD-R


Nit-Occlud® Lê VSD


Unique flexible coil occluder for the closure of Ventricular Septal Defects (VSD). Perimembranous (aneurysmatic) and muscular VSDs can be treated. In all 350 cases (1, 2) no permanent heart (AV) block was reported.


Benefits

Patented coil design with polyester fibres  The coil design with securely attached polyester fibres results in a rapid, effective and safe VSD occlusion.

Outstanding adaptation properties  Nit­-Occlud® Lê VSD adapts perfectly to the anatomy of per­imembranous VSDs (especially in those with aneurysmatic formation) as well as muscular VSDs.

Safety for the patient’s benefit  Due to its flexible design, no permanent AV-Blocks  occurred in more than 350 (1, 2) reported cases.

Broad range of different sizes  Nit-Occlud® Lê VSD is available in diameters 8, 10, 12, 14 and 16 mm (largest distal winding), making the implant suit­able for closing VSDs of various shapes and sizes.

Small Delivery Sheaths  Nit-Occlud® Lê VSD can be deployed through small introducer sheaths of 6F and 7F.

Trials and registries
1  "International Multicentre Clinical Device Investigation on Safety and Effectiveness of the Nit-Occlud® Lê VSD Spiral Coil System for VSD Occlusion" (clinicatrials.gov identifier NCT00390702).
2 "The Nit-Occlud® Lê VSD Registry", publication in preparation

Details

  • Flexible and adaptive design
  • Pre-mounted in 5F and 6F delivery catheter
  • Used along with a 6F and 7F long sheath
  • Radiopaque
  • MR conditional
  • Single­use 
  • Repositionable prior to release

Practice

Case 1: Perimembranous VSD 
 Patient: male, 10 years old
 VSD size: ∅ RV 4 mm, ∅ LV 9 mm
 Distance to aortic valve: 3 mm
 Selected coil: 10 × 6 mm
 Clinical outcome: closed no AV-Block or other arrhythmias 

Case 2: Perimembranous VSD 
 Patient: female, 7 years old
 VSD size: ∅ RV 6 mm, ∅ LV 13 mm
 Distance to aortic valve: 4 mm
 Selected coil: 14 × 8 mm
 Clinical outcome: closed no AV-Block or other arrhythmias 

Case 3: Muscular VSD 
 Patient: male, 25 years old
 VSD size: ∅ RV 6 mm, ∅ LV 15 mm
 Selected coil: 14 × 8 mm
 Clinical outcome: closed no AV-Block or other arrhythmias 

Knowledge

The principal concept of Nit­Occlud® Lê VSD is to tamponade the VSD passageway. For that purpose, the implant has a double coil layer at its proximal portion, one inside the other, to fill the VSD with sufficient material.

During deployment, the inner layer is configured first (Fig. A). To increase the amount of occluding material inside the defect, reversed windings of the outer layer are added onto the inner windings (Fig. B).

As opposed to rigid double-umbrella designs of other technol­ogies, VSD coil occlusion has been proven to be more gentle to the cardiac anatomy: In more than 350 Nit­Occlud® Lê VSD implantations (1, 2) no permanent heart block has been reported.

Fig. A

Fig. B

Handling

Device Selection
A coil with a distal diameter (D) of at least twice the minimal diameter of the VSD on the right ventricular side and equal to, or 1–2 mm greater than, the diameter of the VSD at the left ventricular opening is appropriate and should be selected.

P = proximal, D = distal

Application Range

For the interventional occlusion of ventricular septal defects using catheter techniques.

VSD with perimembranous (aneurysmatic) and muscular location can be treated with Nit-Occlud® Lê VSD.

Configurations

The Nit-Occlud® Lê VSD is available in the sizes 8 × 6, 10 × 6, 12 × 6, 14 × 8, and 16 × 8 mm corresponding to the distal and proximal diameters respectively.

The 14 × 8 mm and 16 × 8 mm devices have an increased axial stiffness, which improves the adaptation to the septum and the fixation of the coil in larger defects.

Manufacturer

pfm medical ag

Wankelstraße 60

50996 Köln, Germany

Ordering Information


Downloads

Brochure Nit-Occlud® Lê VSD

IFU Nit-Occlud® Lê VSD

MR-Kompatibilität Nit-Occlud® Lê VSD 

CE-certificate Nit-Occlud® Lê VSD

Video