Nit-Occlud® Lê VSD

Benefits
Patented coil design with polyester fibres
The coil design with securely attached polyester fibres results in a rapid, effective and safe VSDVentricular septal defect refers to a hole in the wall separating the two lower chambers (ventricles) of the heart… occlusion.
Safety for the patient’s benefit
Due to its flexible design, no permanent AV-Blocks occurred in more than 3501 reported cases.
Broad range of different sizes
Nit-Occlud® Lê VSDVentricular septal defect refers to a hole in the wall separating the two lower chambers (ventricles) of the heart… 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 VSDVentricular septal defect refers to a hole in the wall separating the two lower chambers (ventricles) of the heart… can be deployed through small introducer sheaths of 6 F and 7 F.
[1] R. Kozlik-Feldmann (2018): Safety and Effectiveness of the Nit-Occlud Lê VSD Coil System for VSD Occlusion: Long-term Outcome in 93 Patients
Product Details
- Pre-mounted in 5 F and 6 F delivery catheter
- Used along with a 6 F and 7 F long sheath
- Radiopaque
- MR conditional
- Single use
- Repositionable prior to release
Technical Data
- Length implantation catheter: 105 cm
Knowledge
The principal concept of NitOcclud® Lê VSDVentricular septal defect refers to a hole in the wall separating the two lower chambers (ventricles) of the heart… is to tamponade the VSDVentricular septal defect refers to a hole in the wall separating the two lower chambers (ventricles) of the heart… passageway. For that purpose, the implant has a double coil layer at its proximal portion, one inside the other, to fill the VSDVentricular septal defect refers to a hole in the wall separating the two lower chambers (ventricles) of the heart… with sufficient material.
During deployment, the inner layer is configured first. To increase the amount of occluding material inside the defect, reversed windings of the outer layer are added onto the inner windings.
As opposed to rigid double-umbrella designs of other technologies, VSDVentricular septal defect refers to a hole in the wall separating the two lower chambers (ventricles) of the heart… coil occlusion has been proven to be more gentle to the cardiac anatomy: In more than 350 NitOcclud® Lê VSDVentricular septal defect refers to a hole in the wall separating the two lower chambers (ventricles) of the heart… implantations1 no permanent heart block has been reported.
Device Selection
A coil with a distal diameter (D) of at least twice the minimal diameter of the VSDVentricular septal defect refers to a hole in the wall separating the two lower chambers (ventricles) of the heart… on the right ventricular side and equal to, or 1–2 mm greater than, the diameter of the VSDVentricular septal defect refers to a hole in the wall separating the two lower chambers (ventricles) of the heart… at the left ventricular opening is appropriate and should be selected.
Konfigurations
The Nit-Occlud® Lê VSDVentricular septal defect refers to a hole in the wall separating the two lower chambers (ventricles) of the heart… 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 septumThe septum (from the Latin "saeptum" - border, fence) is a wall. The cardiac septum separates the left and right part of the heart. and the fixation of the coil in larger defects.
[1] R. Kozlik-Feldmann (2018): Safety and Effectiveness of the Nit-Occlud Lê VSD Coil System for VSD Occlusion: Long-term Outcome in 93 Patients
Application area
- For the interventional occlusion of ventricular septal defects using catheter techniques - either perimembranous (aneurysmatic) or muscular VSDVentricular septal defect refers to a hole in the wall separating the two lower chambers (ventricles) of the heart…
Manufacturer
- pfm medical gmbh, Wankelstr. 60, 50996 Cologne, Germany
Ordering Information
Article number | Coil Ø | Outer Ø implant. catheter | Delivery unit (VPE) |
---|---|---|---|
149086V1 | 8 x 6 mm | 6 F | 1 pcs |
149106V1 | 10 x 6 mm | 6 F | 1 pcs |
149126V1 | 12 x 6 mm | 6 F | 1 pcs |
149128V1 | 12 x 8 mm | 7 F | 1 pcs |
149148V1 | 14 x 8 mm | 7 F | 1 pcs |
149168V1 | 16 x 8 mm | 7 F | 1 pcs |
Downloads
Instructions for use can be found in our Download Center.
Additional information
Please note:
Not all products are available in every country.
Please refer to the respective country websites:
For all other countries please use the contact form to enquire about availability for your country.