Protembis has announced establishment of a scientific advisory board (SAB) to provide objective advice and contribute to the strategic plans of the company.
The SAB will be comprised of Martin Leon (Columbia University, New York, USA), Anita Asgar (Northwestern Medicine, Evanston, USA), Samir Kapadia (Cleveland Clinic, Cleveland, USA), and Nicolas van Mieghem (Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands).
Protembis is currently enrolling patients in the PROTEMBO Pivotal investigational device exemption (IDE) trial, which aims to show that the ProtEmbo cerebral embolic protection system is superior to contemporary practice in reducing new cerebral lesion volume during transcatheter aortic valve implantation (TAVI) when assessed by diffusion-weighted MRI.
The novel trial randomises ProtEmbo against a hybrid control group: half receiving no cerebral embolic protection and half receiving the Sentinel (Boston Scientific) device.
The trial is led by Roxana Mehran (Mount Sinai, New York, USA) as the chair of the study executive committee, with Susheel Kodali (New York Presbyterian Hospital, New York, USA), Raj Makkar (Cedars Sinai, Los Angeles, USA) and Stephan Haussig (Herzzentrum, Dresden, Germany) as the global co-principal investigators.
In a press release, Protembis says that the new advisory board will provide overarching scientific and clinical strategic guidance, advise on emerging trends and opportunities, and provide expert counsel on scientific and clinical matters.
The SAB is chaired by Leon, who is professor of medicine at New York’s Columbia University Irving Medical Center and chief innovation officer and the director of the Cardiovascular Data Science Center for the Division of Cardiology.
“I have been impressed by the Protembis management and their innovative US pivotal clinical trial design that utilises MRI [magnetic resonance imaging] endpoints. I am looking forward to collaborating with the other members of the SAB to advise on the technology’s future evolution as the field of TAVI expands into lower risk, asymptomatic, and younger patients,” said Leon.
Having recently moved from the Montreal Institute of Cardiology where she was medical director of the structural heart programme, Asgar is an associate professor and the medical director for structural and interventional cardiology at Northwestern Medicine in Evanston/Chicago, USA. She has published and co-authored almost 200 scientific papers in peer-reviewed journals. Her research interests include the treatment and management of valvular heart disease and cost-effectiveness analyses.
Kapadia is chairman of cardiology in the Robert and Suzanne Tomsich Department of Cardiovascular Medicine in Cleveland. He has been instrumental in the design and execution of the high profile cerebral embolic protection trials as the co-principal investigator of the Sentinel IDE trial and principal investigator of the PROTECTED TAVR trial.
Van Mieghem is a professor of medicine and the director of interventional cardiology at the Thoraxcenter Erasmus University Medical Center in Rotterdam. He was the principal investigator of the MISTRAL-C European trial of the Sentinel device and has been author or co-author on almost 30 publications specifically in the field of cerebral embolic protection.
“We are pleased to announce the creation of this SAB with such a roster of global recognised thought leaders,” said Protembis co-chief executive officers Karl von Mangoldt and Conrad Rasmus. “To be able to cooperate closely with the members and to benefit from their extensive clinical and strategic knowledge is a privilege. Their guidance will be critical as we map our strategic path forward.”
