Only CEP Trial Designed as a Superiority Trial using DW-MRI to Demonstrate Effectiveness Against the Currently Approved Sentinel Device
Protembis GmbH (Protembis), a privately-held emerging cardiovascular medical device company, announced today the enrollment of the first patient in the PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial (NCT05873816). The trial will enroll between 250-500 randomized patients undergoing transcatheter aortic valve replacement (TAVR) in the USA and Europe with the ProtEmbo System, an innovative next generation cerebral embolic protection device (CEP) providing complete 3-vessel coverage of the cerebral arteries. The PROTEMBO study aims to show superiority of the ProtEmbo System against a hybrid control group: half receiving no CEP and half receiving the Sentinel CEP (Boston Scientific, Marlborough, MA, USA), which covers just two of the three cerebral arteries that originate from the aortic arch. 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.
The trial will be led by Dr Susheel Kodali (New York Presbyterian Hospital, NY, USA), Dr Raj Makkar (Cedars Sinai, Los Angeles, CA, USA) and Dr Stephan Haussig (Herzzentrum, Dresden, Germany), as the designated Global Co-Principal Investigators, with Dr Roxana Mehran (Mount Sinai, NY, USA) as the Chair of the Study Executive Committee.
"The novel 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," said Dr Mehran. "The results will give the physician community increased confidence in offering patients cerebral protection when they undergo their TAVR procedures."
"We are proud to be the first center to enroll a patient into this innovative international study," said Dr Kodali. "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."
"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," said Karl von Mangoldt and Conrad Rasmus Co-CEOs of Protembis.
About ProtEmbo and Protembis
The ProtEmbo Cerebral Protection System is an intra-aortic filter device that protects the entire brain from embolic material liberated during 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 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.
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Contacts:
Protembis GmbH
Conrad Rasmus Karl von Mangoldt
+49(0)241 9903 3622
management[at]protembis.com
www.protembis.com
