The IrisFIT Patent Foramen Ovale Closure Device in Patients With History of Cryptogenic Embolization

Marius Hornung, Stefan C Bertog, Sameer Gafoor, Markus Reinartz, Laura Vaskelyte, Ilona Hofmann, Kolja Sievert, Predrag Matic, Iris Grunwald, Horst Sievert

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)


BACKGROUND: The aim of this study was to assess safety, efficacy, and clinical outcome of the IrisFIT PFO Closure System (Lifetech Scientific) for transcatheter closure of patent foramen ovale (PFO) in patients with a history of cryptogenic stroke, transient ischemic attack (TIA), or peripheral embolization.

PATIENTS AND METHODS: We report the results of 60 consecutive patients undergoing PFO closure with the IrisFIT occluder for secondary prevention of paradoxical embolization. All cases were analyzed for periprocedural and device-related adverse events up to 12 months after implantation. In addition, the patients were evaluated for complete defect closure with transesophageal echocardiography (TEE) after 1 month, 6 months, and (if indicated) 12 months. Mean patient age was 53 ± 14 years and 37 patients (62%) were males. All patients had a history of at least 1 cryptogenic stroke, TIA, or peripheral embolization.

RESULTS: Technical success was achieved in all 60 procedures. The mean procedure time was 28 ± 11 minutes. There were no periprocedural or device-related complications up to 12 months after the implant. Successful defect closure at 6 months post device implantation was achieved in 56 cases (93.3%). Within 12 months of follow-up, 2 patients had recurrent TIAs, both with complete PFO sealing at the last TEE prior to the event.

CONCLUSION: The IrisFIT PFO Closure System can be used safely and with high technical success for secondary prevention of cryptogenic stroke or peripheral embolization.

Original languageEnglish
Pages (from-to)319-324
Number of pages6
JournalJournal of Invasive Cardiology
Issue number11
Early online date15 Sept 2019
Publication statusPublished - Nov 2019


  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Cardiac Catheterization/methods
  • Cardiac Surgical Procedures/methods
  • Echocardiography, Transesophageal
  • Embolism/etiology
  • Female
  • Follow-Up Studies
  • Foramen Ovale, Patent/complications
  • Humans
  • Male
  • Middle Aged
  • Product Surveillance, Postmarketing/methods
  • Prosthesis Design
  • Retrospective Studies
  • Septal Occluder Device
  • Young Adult


Dive into the research topics of 'The IrisFIT Patent Foramen Ovale Closure Device in Patients With History of Cryptogenic Embolization'. Together they form a unique fingerprint.

Cite this