Occlutech Secures Conditional FDA IDE Approval for Pivotal OCCLUFLEX Trial of Flex II PFO Occluder

SCHAFFHAUSEN, Switzerland, August 16, 2021 /PRNewswire/ --Occlutech Holding AG (hereinafter referred to as "Occlutech"), one of the world's leading providers of minimally invasive structural heart disease devices, announced that its Investigational Device Exemption (IDE) application for the pivotal OCCLUFLEX study has received conditional approval from the U.S. Food and Drug Administration ("FDA"). The study will compare patent foramen ovale ("PFO") closure using Occlutech's Flex II PFO Occluder with the standard of care for PFO closure in patients with cryptogenic stroke.

Occlutech today announced that, for a prospective, randomized, multicenter, and controlled clinical study ("OCCLUFLEX"), the FDA has conditionally granted Occlutech an IDE, which aims to compare the efficacy of PFO closure performed using Occlutech's Flex II PFO Occluder with the standard of care in patients with cryptogenic stroke.

The IDE allows Occlutech's PFO occluder to be used in clinical studies to collect safety and effectiveness data in support of a Premarket Approval ("PMA"). This marks a key milestone in Occlutech's strategy to capture the significant U.S. market opportunity for its PFO occluder, which has already received regulatory approval in over 60 markets.

Occlutech CEO Sabine Bois commented:

“FDA’s conditional approval represents another significant milestone in our strategy to enter the U.S. market, which accounts for approximately 30% of the global structural heart defect occluder market. Given the attractive pricing and reimbursement framework, the United States stands as a potential key market for Occlutech. Earlier this year, we established a Chicago-based subsidiary dedicated to marketing, distribution, logistics, and sales. We anticipate completing patient enrollment by 2025, concurrently finalizing the Premarket Approval (PMA) process, and expect to secure FDA approval for the U.S. market in 2026.”

Patient recruitment is expected to begin in the second half of 2021. The primary and secondary endpoints of the study, namely PFO closure and recurrent stroke, will be evaluated during a 12-month patient follow-up period.

AboutPFO 

PFO is a common structural heart defect in which the foramen ovale fails to close completely after birth, resulting in an opening between the left and right atria. It affects approximately 25% of the global population.^[1]

Typically, blood clots formed outside the heart can pass directly from the right atrium through a PFO without being filtered by the lungs as would normally occur. These clots may occlude small blood vessels; if they lodge in the brain, they can cause a stroke.

OcclutechofFlex II PFO`Occluder`Approved in over 60 markets worldwide, enabling physicians to perform minimally invasive closure of a patent foramen ovale (PFO). Occlutech’s PFO occluder has been proven effective in stroke prevention, reducing the relative risk of recurrence by 97%.^[2]The average procedure time for PFO closure is less than 30 minutes, with an even shorter fluoroscopy time.^[3](X-ray exposure), contributing to the device's excellent performance and safety.^[4]

For more information on company products and the Occlutech PFO Occluder, or to inquire about participating in our patient registry, please visit the Occlutech website.www.occlutech.com, or directly viainfo@occlutech.comContact us.

^[1] Krasuski, R. (2017). Closure of Patent Foramen Ovale After Stroke: Who Benefits?[PowerPoint Presentation]. SlideShare.https://www.slideshare.net/DukeHeartCenter/closure-of-patent-foramen-ovale-after-stroke-who-benefits

^[2] Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke Mas et al. (N Engl J Med 2017; 377:1011-1021).

^[3] Trabattoni, D., Gaspardone, A., Sgueglia, G. A., Fabbiocchi, F., Gioffrè, G., Montorsi, P., Calligaris, G., Iamele, M., De Santis, A., & Bartorelli, A. L. (2017). AMPLATZER versus Figulla occluder for transcatheter patent foramen ovale closure. EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 12(17), 2092–2099. https://doi.org/10.4244/EIJ-D-15-00499

^[4] Snijder, R., Renes, L. E., Suttorp, M. J., Ten Berg, J. M., & Post, M. C. (2019). Percutaneous patent foramen ovale closure using the Occlutech Figulla device: More than 1,300 patient-years of follow up. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 93(6), 1080–1084. https://doi.org/10.1002/ccd.27984