The pfm medical occlusion system, specifically developed for the trans-catheter occlusion of medium to large PDAs (Persistent Ductus Arteriosus). The patented nitinol wire mesh is shaped into a cylindrical plug with a retention disc. Sewn in polyester patches promote endothelialisation and accelerate occlusion.
Patented single-wire design The implant is knitted from a single nitinol wire. This gives the distal disc a very low profile with no connecting hubs.
Re-inforced retention disc The re-inforced retention disc facilitates the implantation. The polyester fabric facing the aorta promotes accelerated endothelialisation.
Membranes for immediate closure 2–4 membranes (depending on the size) are sewn into the implant and one membrane is sewn at the aortic face to ensure immediate closure in the cathlab and to promote endothelialisation.
Flexible adaptive design Optimal compromise between flexibility and strength, to adapt to various ductus anatomies and to close even larger PDAs.
Safe and simple device release The unique release mechanism is easy of use, while enabling a soft and tension free release.
- Flexible and adaptive design
- Single-wire knit
- Immediate closure
- Pre-mounted system
- Radiopaque markers
- MR conditional
- Repositionable and retrievable prior to release
Patient: female, 10 years old, 33 kg
PDA measurements: conical type (A) D1: 5,09 mm, D2: 13,3 mm, L: 10,02 mm
Selected PDA-R: Ref 160106 (D=16, S=10, L=11; 4 membranes)
Clinical outcome: closed
Patient: female, 2 years old, 13 kg
PDA measurements: tubular type (C), D1: 3,9 mm, D2: 6,1mm, L: 16,2 mm
Selected PDA-R: Ref 160104 (D=12, S=7, L=8.5; 3 membranes)
Clinical outcome: closed
pfm medical’s own development
The Nit-Occlud® PDA-R is an occlusion system developed by pfm medical ag specifically for closing PDAs. It was developed for the occlusion of fairly large PDAs and completes the occluder product range that includes the Nit-Occlud PDA Flex, Medium and Stiff. These devices have already been used very successfully for closing smaller and medium-sized PDAs.
This is now the third generation of PDA occlusion systems from pfm medical ag. Thanks to the highly flexible shield configuration with the specially designed retention disc, the Nit-Occlud® PDA-R atraumatically conforms to the anatomy of the PDA.
The easy-to-operate, patented application system makes it possible to reposition the implant before it is actually released. For the sake of optimum user-friendliness, the Nit-Occlud® PDA-R is pre-mounted in the application system and ready for use in 5–9 F implantation catheters.
From lateral projection of the aortogramm
The selection of the device is dictated by the minimum diameter of the defect: The stent diameter of the device must be at least 1.5 to 2 times greater than the minimum diameter (md) of the defect.
(B) Measure the aortic ampulla diameter (am)
(C) Measure the length (Id) between the pulmonary and aortic orifice
PA = Pulmonary artery
Ao = Aorta
md = Minimum diameter
am = Ampulla diameter
Id = Length of ductus
Functions & Processes
Due to the single-wire knit of Nit-Occlud® PDA-R, the distal disc has a low profile without protruding hubs. The rim of the disc is re-inforced to facilitate implantation and to avoid pull through.
Am Söterberg 4
66620 Nonnweiler-Otzenhausen, Germany
|REF||Disc||Introducer sheath||Length||Introducer length||Stent||PU|
|160102||8 mm||6 F||6.5 mm||90 cm||4 mm||1|
|160103||10 mm||6 F||7 mm||90 cm||5.5 mm||1|
|160104||12 mm||6 F||8.5 mm||90 cm||7 mm||1|
|160105||14 mm||7 F||9.5 mm||90 cm||8.5 mm||1|
|160106||16 mm||8 F||11 mm||90 cm||10 mm||1|
|160107||18 mm||8 F||12 mm||90 cm||11.5 mm||1|
|160108||20 mm||10 F||13.5 mm||90 cm||13 mm||1|