FDA Approves IDE Study of the ProtEmbo Cerebral Embolic Protection System

Protembis GmbH (Protembis) has received U.S. Food and Drug Administration (FDA) approval for its PROTEMBO Pivotal IDE Trial (NCT05873816).

The study will recruit between 250-500 randomized patients undergoing transcatheter aortic valve replacement (TAVR) in the United States and Europe with the next-generation ProtEmbo complete three-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), 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.
 
“We are excited to embark on this landmark trial as it is the only randomized trial in the space that is designed to examine the superior effectiveness of a next generation CEP technology to the current standard of care,” said Dr. Roxana Mehran (Mount Sinai, New York, N.Y.), chair of the Study Executive Committee. The trial will be led by Drs. Susheel Kodali (New York Presbyterian Hospital, New York, N.Y.), Raj Makkar (Cedars Sinai, Los Angeles), and Stephan Haussig (Dresden Herzzentrum, Dresden, Germany), as the designated global co-principal investigators.

The ProtEmbo System is an intra-aortic filter device that protects the brain from embolic material liberated during the TAVR procedure. It is a low-profile non thrombogenic system that shields all cerebral vessels, delivered through the left radial artery for optimal placement and stability. This is an ideal access site enabling physicians to avoid interference with TAVR equipment which is typically delivered through the femoral artery.
 
“We are delighted to announce that the pivotal IDE trial has been approved by the 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. The significant progress made reflects the close collaboration between our Global Steering Committee, our clinical research organization, and core lab partners in planning this complex trial,” Protembis Co-CEOs Karl von Mangoldt and Conrad Rasmus.
 
Protembis is a privately held emerging medical device company that has developed the ProtEmbo Cerebral Protection System. The company strives to provide a simple and reliable solution to protect patients from brain injury during left-sided heart procedures, improving patient quality of life and reducing overall healthcare costs associated with brain injury during such procedures. The ProtEmbo System is currently undergoing clinical investigations.