Protembis Announces FDA Approval of its Pivotal Investigational Device Exemption (IDE) Study
Novel Adaptive Superiority Trial Design of ProtEmbo® Cerebral Embolic Protection (CEP) System
AACHEN, Germany–(BUSINESS WIRE)–Protembis GmbH (Protembis) a privately-held emerging cardiovascular medical device company, announced today the FDA has approved the PROTEMBO Pivotal IDE Trial (NCT05873816). The trial will recruit between 250-500 randomized patients undergoing TAVR in the USA and Europe with the next generation ProtEmbo’s complete 3-vessel cerebral artery protection aiming to show superiority against a hybrid control group: half receiving no CEP and half receiving the Sentinel CEP (Boston Scientific, Minneapolis, USA), which covers just two of the three cerebral arteries that originate from the aortic arch. The primary DW-MRI efficacy endpoint will use a novel adaptive statistical approach that includes pre-specified interim analyses with the possibility of early termination in the instance of superiority. The primary safety endpoint is the rate of major adverse cardiac and cerebrovascular events (MACCE) assessed at 30-days, with stroke neurologists adjudicating the neurological events.
