Nit-Occlud® Lê VSD


Unique flexible coil occluder for the closure of Ventricular Septal Defects (VSD). Perimembranous (aneurysmatic) and muscular VSDs can be treated. 


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

Nit-Occlud® Lê VSD
REFCoil diameterImplantation catheterImplantation catheter lengthPU
1490868 x 6 mm6 F105 cm1
14910610 x 6 mm6 F105 cm1
14912612 x 6 mm6 F105 cm1
14912812 x 8 mm7 F105 cm1
14914814 x 8 mm7 F105 cm1
14916816 x 8 mm7 F105 cm1

Video