Occlutech Holding has announced the conditional US 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.
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).
Sabine Bois, CEO of Occlutech, says: “The conditional FDA approval is another significant milestone in our plan to enter the USA. Accounting for approximately 30% of the global structural heart defect occluder market, and characterised by an attractive pricing and reimbursement system, the USA 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 enrolment of patients in 2025 while finalising the premarket approval and anticipate to receive an FDA market approval for the USA in 2026.”
Patient enrolment 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.