Occlutech Granted Conditional Approval of IDE for OCCLUFLEX PFO Study in the United States

August 16, 2021—Occlutech Holding AG, the Switzerland-based provider of minimally invasive structural heart disease devices, announced the conditional approval from the FDA for its investigational device exemption (IDE) application to conduct the OCCLUFLEX pivotal study in the United States.

According to the company, the prospective, multicenter, randomized, controlled OCCLUFLEX clinical study aims to compare outcomes of patent foramen ovale (PFO) closure with the Occlutech 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 from the FDA.

Patient enrollment in the study 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.

The company stated that the Occlutech Flex II PFO occluder, which has regulatory approvals in more than 60 markets globally, has been proven effective for stroke prevention, reducing the relative risk of recurrent stroke by 97%. The mean procedure time for PFO closure is less than 30 minutes with decreased fluoroscopic time, contributing to the device’s record of performance and safety.

“The conditional FDA approval is another significant milestone in our plan to enter the United States,” commented Occlutech’s Chief Executive Officer Sabine Bois in the company’s press release. “Accounting for approximately 30% of the global structural heart defect occluder market, and characterized by an attractive pricing and reimbursement system, the United States is a potential key market for Occlutech.”

Bois continued, “Earlier this year, we set up a subsidiary in Chicago, Illinois, 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 United States in 2026.”