Occlutech ASD Occluder​

Designed for safety
and excellence

The design of the Flex II ASD Occluder results in a septum alignment which increases its feasibility and patient safety during implantation.1 Recent studies found that transcatheter closure of isolated secundum atrial septal defects using the novel design of the Occlutech ASD Occluder was safe, effective and had a closure rate of 97.3 % with an excellent outcome during the 12-month follow-up period.2,3

Product features

  • Optimized braiding pattern and less material at left atrial disc.
  • Titanium oxide-covered Nitinol shows the best values of biocompatibility4 and minimum nickel release.5
  • Spunbonded PET-patch allows for fast endothelialization.
  • The unique ball-connection between pusher and occluder safely locks it, while it freely follows the anatomy. Once in place it is easy and quick to deliver.6

 

Clinical benefits

  • Lower pull in forces and improved delivery sheath compatibility.7
  • Reduced material exposure.7
  • Significantly reduced mean procedure and fluoroscopic time compared to other devices (34%).6
Occlutech ASD Occluder

The Flex II ASD has not received FDA Premarket Approval.

ASD
ASD material and design characteristics

3D TEE image of an implanted Occlutech
ASD Occluder.

Perfect alignment of the Occluder to the Septum.9

50° angulation of Flex Pusher vs Occluder hub.

 
Info

Literature

Content references:
  1. Catheter Cardiovasc Interv. 2008 Krizanic F Optimal septum alignment of the Figulla® Flex occluder to the atrial septum in patients with secundum atrial septal defects
  2. Archives of Cardiovascular Diseases 2011
    Cansel M Early single clinical experience with the new Figulla ASD Occluder for transcatheter closure of atrial septal defect in adults.
  3. Haas NA et.al. Closure of Secundum Atrial Septal Defects by Using the Occlutech Occluder Devices in More Than 1300 Patients: The IRFACODE Project: A Retrospective Case Series.
  4. Castleman LS et. al. Biocompatibility of Nitinol Alloy as an lmplant Material. Journal of Biomedical Materials Research 97 6; 10:695.
  5. Electrochemical Characterization of Nitinol Occluder, Natural and Medical Sciences Institute at the University of Tubingen, mNl<0,014 µg/(cm *d). Internal classified source.
  6. 2018_Kenny A randomized, controlled, multi-center trial of the efficacy and
    safety of the Occlutech Figulla Flex-II Occluder compared to
    the Amplatzer Septal Occluder for transcatheter closure of
    secundum atrial septal defects
  7. ASD_ALL_PD_vers04
  8. 2013_Zuh_Oxidation of Nitinol and its Effect on Corrosion Resistance
  9. P17F02.030.04