Nit-Occlud® Lê VSD

Nit-Occlud® Lê VSD
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pfmmedical´s unique Nitinol coil design developed for the transcatheter occlusions fo Ventricular Septal Defects (VSD). The patented coil design with polyesterfibres for accelerated occlusion is intended for the closure of perimembranous and muscular VSDs.

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 3501,2 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 implantation 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 (ClinicalTrials.gov ID NCT00390702)
[2] CEV241119ESCH1401_data_evulation_VSD-registriy

Product Details

  • Pre-mounted in 6 F and 7 F delivery catheter
  • Used along with a 6 F and 7 F implantation 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… implantations1,2 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.

Configurations
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, 12 x 8, 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 (ClinicalTrials.gov ID NCT00390702)
[2] CEV241119ESCH1401_data_evulation_VSD-registriy

Application area

Manufacturer

  • pfm medical gmbh, Wankelstr. 60, 50996 Cologne, Germany

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Ordering Information

Article numberCoil ØOuter Ø implant. catheterDelivery 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

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Additional information