Occlutech has announced that the US Food and Drug Administration (FDA) has approved the Occlutech ASD Occluder and Occlutech Pistol Pusher for the treatment of atrial septal defects (ASD).
With this approval, Occlutech will immediately begin commercialisation in an exclusive partnership with distributor B Braun Interventional Systems Inc.
Sabine Bois, Occlutech CEO, commented: “Today marks a momentous occasion for Occlutech and a significant leap forward in our commitment to advancing healthcare around the globe. I am thrilled the FDA has granted approval for the Occlutech ASD Occluder and Occlutech Pistol Pusher. Our mission has always been to improve the quality of life for patients; indeed, we have sold over 90,000 of our ASD devices outside of the USA. Now, with the FDA’s approval, we are poised to leverage our experience in the largest congenital and structural heart disease market in the world, with ASD closure representing a $40 million market in the US with solid growth predicted We extend our deepest gratitude to the patients, partners and all stakeholders who have been instrumental in this journey.”
In an agreement signed May 2022, B Braun Interventional Systems will immediately initiate the US commercialisation activities for the Occlutech ASD Occluder with the support of the global Occlutech team.
“We are honoured to bring the trusted Occlutech ASD Occluder, with its strong body of clinical evidence into our portfolio of devices developed to treat congenital heart defects,” said Dave Mittl, VP Sales and Marketing, B Braun Interventional Systems. “Our legacy at B Braun Interventional Systems has been to deliver solutions to interventionalists treating these often-overlooked patients. This portfolio addition builds on that commitment.”