Protembis Begins Study of its Intra-Aortic Filter Device

Protembis GmbH (Protembis) has enrolled the first patient in a study to measure the performance of its ProtEmbo System against Boston Scientific Corp.’s Sentinel CEP in patients undergoing transcatheter aortic valve replacement (TAVR). 

The PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial will recruit 250-500 randomized TAVR patients in the United States and Europe. The trial will be led by Dr. Susheel Kodali (New York Presbyterian Hospital, New York, N.Y.), Dr. Raj Makkar (Cedars Sinai, Los Angeles), and Dr. Stephan Haussig (Herzzentrum, Dresden, Germany), as global co-principal investigators, with Dr. Roxana Mehran (Mount Sinai, New York, N.Y.) as the Study Executive Committee chair.

“We are delighted to announce that the first patient has been enrolled in the trial, and that we are executing a cadenced plan to activate the other investigational sites in the next few months. We would like to express our gratitude to the teams at the sites for the hard work that each has invested in the study startup phase. This significant progress reflects the close collaboration between our study executive committee, our clinical research organization, and core lab partners in planning this complex trial,” Protembis Co-CEOs Karl von Mangoldt and Conrad Rasmus said.

The PROTEMBO study will assess the ProtEmbo System against a hybrid control group: half will not receive a cerebral embolic protection (CEP) device and half will be treated with Boston Scientific’s Sentinel CEP product, which covers two of the three cerebral arteries that originate from the aortic arch. The ProtEmbo System provides three-vessel coverage of cerebral arteries.

“The adaptive statistical design of this clinical study will answer several important unanswered questions about the role of three-vessel cerebral protection in reducing new lesions in all areas of the brain,” Mehran said. “The results will give the physician community increased confidence in offering patients cerebral protection when they undergo their TAVR procedures.”

The primary diffusion-weighted magnetic resonance imaging (DW-MRI) efficacy endpoint will use a novel adaptive statistical approach that includes pre-specified interim analyses with the possibility of early study completion in the instance of superiority. The primary safety endpoint is the rate of major adverse cardiac and cerebrovascular events (MACCE) assessed at 30 days.
 
“We are proud to be the first center to enroll a patient into this innovative international study,” Kodali stated. “The requirement for DW-MRI assessment means that we will be able to accurately quantify the fundamental effect of the technology on reducing the size and frequency of new cerebral lesions, which are very common during the TAVR procedure.”
 
The ProtEmbo Cerebral Protection System is an intra-aortic filter device that protects the entire brain from embolic material liberated during transcatheter aortic valve replacement (TAVR). 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 typically delivered through the femoral artery. 
 
Protembis is a privately held emerging medical device company based in Germany that is developing a solution to protect patients from brain injury during left-sided heart procedures.