Protembis Announces FDA Approval of its Pivotal Investigational Device Exemption (IDE) Study
Protembis GmbH (Protembis) a privately-held emerging cardiovascular medical device company, announced today the FDA has approved the PROTEMBO Pivotal IDE Trial (NCT05873816).
- Protembis GmbH (Protembis) a privately-held emerging cardiovascular medical device company, announced today the FDA has approved the PROTEMBO Pivotal IDE Trial (NCT05873816).
- 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.
- “We are delighted to announce that the pivotal IDE trial has been approved by the US FDA.
- The Protembis team is working hard with our investigational sites, which are high volume TAVR centers and world-renowned academic centers of excellence, to ensure study activation is achieved expeditiously.