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Nit-Occlud® PFO


The Nit-Occlud® PFO occluder is a new generation of occlusion systems, leading to optimal performance and effective closure. Nit-Occlud® PFO is a double-umbrella occluder with dacron membranes in a unique design: The occluder is knitted from a single Nitinol wire. Therefore, it has a low profile and no protruding clamps. Nit-Occlud® PFO is knitted from a single Nitinol wire, making protruding fixation-clamps obsolete. Nit-Occlud® PFO`s unique single-layer distal disc, reduces the metal used in the left-atrium (LA) by 50%, decreasing the thromboembolic risk.


Benefits

Patented single-wire knit  Due to the single-wire design, there is no need for protruding clamps which are usually used. This results in a very low profile.

Special design  The occluder consists of a double-layer right atrial disc and a single-layer left atrial disc. The thrombo-embolic risk is lowered by reducing the amount of Nitinol being used in the LA (50%).

Accelerated endothelialisation  A polyester membrane facing the LA promotes accelerated endothelialisation.

Various sizes  The Nit-Occlud® PFO is available in diameters of 20 mm, 26 mm and 30 mm.

Easy to use  The easy-to-use application system was developed specifically for Nit-Occlud® PFO procedures. The device is premounted, retrievable and easy to position and to deploy.

Details

  • Single-wire knit
  • No need for protruding clamps to fixe loose wire ends
  • Very low-profile
  • Concave single-layer left atrial disc
  • 50% reduction of metal in the left atrium
  • Good adaption to the septal wall
  • Soft and atraumatic rim
  • LA polyester face accelerating endothelialisation
  • Pre-mounted 9 F and 10 F systems
  • Easy to reposition and to retrieve
  • Simple to release
  • Good radiopacity
  • MR conditional

Practice

Field of structural heart defects; for treating PFO (patent foramen ovale).

The Nit-Occlud® PFO shield is a permanent implant used for closing PFOs. It is inserted in the PFO using minimally invasive catheter technology. The shield consists of Nitinol, a shape memory material, which resembles a double shield in its relaxed state.

Dacron, a synthetic material, is incorporated in the right atrial double disc to achieve a high acute closure rate. The left atrial disc is a single disc in order to accelerate the endothelialisation process. Nit-Occlud® PFO shields are available in various sizes to enable a wide range of PFOs to be treated with the best possible results.

The Nit-Occlud® PFO shield system consists of two main components: the shield and a delivery system including a single applicator.

Handling

Diagnostic Measurements

As a first step, a full transesophageal echocardiographic study must be carried out. If possible, all intracardiac findings which are necessary for the procedure should be included in the study.

Selection of the Nit-Occlud® PFO Umbrella

Selection of the umbrella will depend on the distance between the PFO and the aortic root or between the PFO and the junction of the superior vena cava, as measured in the transesophageal echocardiogram (cf. Tab.: Selection of the Nit-Occlud® PFO umbrella and the recommended Mullins sheath).

A 45° curved 9 F Mullins sheath is recommended for the PFO 20 and 26 umbrella systems, and a 45° curved 10 F Mullins sheath for the PFO 30 umbrella system.

Diameter election of the Nit-Occlud® PFO umbrella
Occluder Type PFO-20, REF 182020 PFO-26, REF 182026 PFO-30, REF 182030
20 mm 26 mm 30 mm
Distance aortic root-PFO ≥11 mm, <14 mm ≥14 mm, <16 mm ≥16 mm
Distance superior vena cava-PFO ≥11 mm, <14 mm ≥14 mm, <16 mm ≥16 mm
Recommended Mullins sheath 45° curved 9FF

45° curved 9F

45° curved 10F

Auxiliary Imaging Procedures

Closure of the PFO is performed in the cardiac catheterisation laboratory under transesophageal echochardiography and x-ray fluoroscopy.

Application Range

Indication:

Primary Indication:

Interventional closure of a diagnostically ascertained patent foramen ovale (PFO) after a neurological event, e.g. transient ischemic attack or stroke.

Relative Indication:

Recent studies show that in some cases of frequent migraine attacks, severity and frequency could be decreased by PFO closure.
Furthermore, recent studies show that in divers with patent foramen ovale, decompression sickness with unknown origin could be decreased by PFO closure. Therefore, in these few cases there is a relative indication for occlusion of a known patent foramen ovale incase of decompression sickness or migraine.

Contraindication:

Pathological or physical conditions that exclude the implantation of a Nit-Occlud® PFO umbrella:

  • Active endocarditis, or active infection at the time of the implantation
  • Anatomical or physiological structures that do not permit transesophageal echocardiography
  • Atrial fibrillation or atrial flutter
  • Closure of other structural cardiac defects than a patent foramen ovale
  • Concomitant cardiac anomalies requiring an operative procedure
  • Hemorrhagic diseases (coagulopathy, tendency to haemolysis)
  • Hypersensitivity to contrast medium or nickel
  • Potential physical influence on intracardiac or intravascular structures from the occluder
  • Recent myocardial infarction
  • The required sheaths cannot be passed through the relevant vessels for access to the PFO
  • Thrombus in a vessel through which access to the PFO is made
  • Thrombus in the vicinity of the implantation site

Manufacturer

pfm medical mepro gmbh

Am Söterberg 4

66620 Nonnweiler-Otzenhausen, Germany

Ordering Information

Nit-Occlud® PFO
REFDiameterImplantation catheterImplantation catheter lengthVPE
18202020 mm9 Fmax. 90 cm1
18202626 mm9 Fmax. 90 cm1
18203030 mm10 Fmax. 90 cm1

Video