Occlutech Holding AG (“Occlutech”), one of the world´s leading providers of minimally invasive structural heart disease devices, announces the conditional U.S. Food and Drug Administration (“FDA”) approval of its Investigational Device Exemption (“IDE”) application to conduct a pivotal study, OCCLUFLEX, comparing Patent Foramen Ovale (“PFO”) closure by Occlutech’s Flex II PFO Occluder to the standard of care for PFO occlusion in patients with cryptogenic stroke.
Occlutech today announces that the FDA has conditionally granted Occlutech an IDE for a prospective, randomized, multi-center, controlled, clinical study (“OCCLUFLEX”), which aims to compare outcomes of PFO closure by Occlutech’s Flex II PFO Occluder to the standard of care in patients with cryptogenic stroke.
The IDE allows Occlutech’s PFO Occluder to be used in a clinical study to collect safety and effectiveness data to support a Premarket Approval (“PMA”). This marks a key milestone in Occlutech’s strategy of capturing the significant U.S. market opportunity for the PFO Occluder, which today has regulatory approvals in over 60 markets.
Sabine Bois, CEO Occlutech, comments:
“The conditional FDA approval is another significant milestone in our plan to enter the U.S. Accounting for approximately 30 percent of the global Structural Heart Defect occluder market, and characterized by an attractive pricing and reimbursement system, the U.S. is a potential key market for Occlutech. Earlier this year we set up a subsidiary in Chicago, focusing on marketing, distribution, logistics and sales. We expect to complete the enrollment of patients in 2025 while finalizing the Premarket Approval and anticipate to receive an FDA market approval for the U.S. in 2026.”
Patient enrollment is expected to commence during the second half of 2021. The study’s primary and secondary endpoints, PFO Closure and recurrent stroke, respectively, will be evaluated at the 12-month patient follow-up.