Nit-Occlud® PDA-R


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.


Benefits

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.

Details

  • Flexible and adaptive design
  • Single-wire knit
  • Immediate closure
  • Pre-mounted system
  • Radiopaque markers
  • MR conditional
  • Single-use
  • Repositionable and retrievable prior to release
Distal View
Lateral View
Proximal View

Practice

Case 1 
 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 
Case 2 
 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 

Knowledge

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.

Handling

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.

(A) Measure the minimal diameter (md) of the ductus
 (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.

Application Range

Nit-Occlud® PDA-R is an implant developed for the trans-catheter closure of the Persistent Ductus Arteriosus (PDA). The device is especially recommended for the closure of medium to large PDAs.

Manufacturer

pfm medical mepro gmbh

Am Söterberg 4

66620 Nonnweiler-Otzenhausen, Germany

Ordering Information

Nit-Occlud® PDA-R
REFDiscIntroducer sheathLengthIntroducer lengthStentPU
1601028 mm6 F6.5 mm90 cm4 mm1
16010310 mm6 F7 mm90 cm5.5 mm1
16010412 mm6 F8.5 mm90 cm7 mm1
16010514 mm7 F9.5 mm90 cm8.5 mm1
16010616 mm8 F11 mm90 cm10 mm1
16010718 mm8 F12 mm90 cm11.5 mm1
16010820 mm10 F13.5 mm90 cm13 mm1

Video