Occlutech’s ASD Occluder Device and Pistol Pusher Delivery System Approved by FDA

January 15, 2024—Occlutech Holding AG, the Switzerland-based provider of minimally invasive structural heart disease devices, recently announced that the FDA has approved the Occlutech ASD occluder and Pistol Pusher for the treatment of atrial septal defect (ASD). The company will immediately begin commercialization of the system in the United States through an exclusive partnership with distributor B. Braun Interventional Systems Inc.

According to the company, the Occlutech ASD occluder is a self-expanding, nitinol, double-disc occlusion device comprised of two umbrella-shaped flexible discs with a “waist” in the middle connecting the two discs. The discs attach to both sides of the atrial septum, bridging the defect and closing the hole. The device is designed to be a lifelong solution to ASD.

“This landmark approval is a huge milestone,” commented Professor Ziyad M. Hijazi, MD, in the company’s press release. “The Occlutech ASD occluder has demonstrated excellent procedural outcomes and a low complication rate per rigorous scientific study and clinical trials of > 5,000 studied patients in retrospective, prospective, and randomized clinical trials as well as comparative meta-analysis. Therefore, to have the device available to our patients in the United States will only serve to help thousands more people in need.” Prof. Hijazi is Chairman, Department of Cardiovascular Diseases and Professor of Pediatrics & Medicine at Sidra Medicine and Weill Cornell Medicine in Doha, Qatar.