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
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
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
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.
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.
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
| REF | Coil diameter | Implantation catheter | Implantation catheter length | VPE |
|---|---|---|---|---|
| 149086V1 | 8 x 6 mm | 6 F | 105 cm | 1 |
| 149106V1 | 10 x 6 mm | 6 F | 105 cm | 1 |
| 149126V1 | 12 x 6 mm | 6 F | 105 cm | 1 |
| 149128V1 | 12 x 8 mm | 7 F | 105 cm | 1 |
| 149148V1 | 14 x 8 mm | 7 F | 105 cm | 1 |
| 149168V1 | 16 x 8 mm | 7 F | 105 cm | 1 |
