Protembis Announces FDA Approval of its Pivotal Investigational Device Exemption (IDE) Study

[#item_full_content]AACHEN, Germany–(BUSINESS WIRE)– #CerebralProtection–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