Nyxoah Gets CE Mark for Genio To Treat Complete Concentric Collapse
Belgium-based Nyxoah has received a CE mark certification that covers a new indication for its Genio system to treat sleep apnea patients with a complete concentric collapse (CCC) of their soft palates.
The CE mark was granted based on data from a clinical trial that showed the Genio system was safe and effective for both CCC and nonCCC patients. This means that patients do not have to undergo a drug-induced sleep endoscopy procedure to determine if they have CCC at the soft palate level before Genio implantation, the company said.
Nyxoah received the FDA’s breakthrough device designation for the Genio system in September.