Occlutech announces first US patient enrolled in important FDA study

Occlutech Holding AG (“Occlutech”), one of the world’s leading providers of minimally invasive
structural heart disease devices, continues its progress in the US market. The company has announced today that the first patient in the United States has been enrolled in the OCCLUFLEX study.
The OCCLUFLEX study is investigating the safety and efficacy of Occlutech’s PFO Occluder compared with the standard of care PFO Occluders approved by the Food and Drug Administration (FDA) in patients who have suffered a PFO-associated stroke.

In 2021, the FDA granted Occlutech IDE approval for a prospective, randomized, multi-center, controlled, clinical study. The study allows Occlutech to collect safety and effectiveness data to support a Premarket Approval (PMA) application to the FDA upon completion.  The OCCLUFLEX study aims to enroll 450 patients in the US, Canada, and Europe. 

An important step in the OCCLUFLEX study was achieved when the first patient in the United States was enrolled at Tufts Medical Center in Boston, Massachusetts by study investigators, Drs. David Thaler and Carey Kimmelstiel. 

“Our team has been involved in PFO Closure trials from their beginning, and we are pleased to be part of another FDA study for patients who suffer from PFO-associated stroke – an all-too-common stroke mechanism in young patients,” says Dr. David Thaler, the Site Neurologist and Steering Committee Member.

 “I am excited to use the Flex II PFO Occluder for patients in this study” said Dr. Kimmelstiel, the Site Interventional Cardiologist, “This study will expand the dataset of PFO Closure in this patient population.” 

“Occlutech has in the past weeks made significant progress on its path to US commercialization. Today, it is with great pleasure that we can announce that the first US patient has been recruited to our important FDA study for our PFO Occluder. We especially thank Drs. David Thaler and Carey Kimmelstiel at Tufts Medical Center in Boston, Massachusetts for their important role and support. Occlutech expect FDA approval of the PFO Occluder in the US by 2026, says Sabine Bois, CEO of Occlutech.”

For more information about the OCCLUFLEX clinical study, please visit https://clinicaltrials.gov.

About PFO
A patent foramen ovale (PFO) is a common structural heart defect in which the foramen ovale does not close completely after birth, resulting in a flap-like opening between the left and right atria of the heart. PFOs exist in around 25 percent of the general population. Blood clots that commonly develop outside the heart may pass directly through the PFO from the right atrium into the left atrium, without passing through the lungs, where they are normally filtered out of the blood. Such clots can cause an occlusion of a small artery and, if located in the brain, cause a stroke. Occlutech’s Flex II PFO Occluder, which has regulatory approval in over 60 markets globally, enables physicians to close the PFO through a minimally invasive procedure.

For additional information about the company’s products, the Occlutech PFO Occluder, or to inquire about participation in our patient registries, please contact us directly at info@occlutech.com.

About Occlutech
Occlutech is a leading specialist provider of minimally invasive structural heart devices, with a mission to improve the quality of life for people with heart conditions. The vision is to become a leading global specialist in cardiac devices, addressing congenital heart defects, stroke prevention and heart failure. Since 2003, the company has developed, manufactured, and commercialized occluders and interatrial shunt products. Occlutech has a broad and proven portfolio, based on proprietary technology, and over 200 patents with more than 146,000 products sold. The company markets and sells its products in around 85 countries. The company has around 290 employees and is a public limited liability company registered in Switzerland. For more information please go to: www.occlutech.com.