Protembis has announced the appointment of J Mocco (Icahn School of Medicine at Mount Sinai, New York, USA) as an independent member of its Board of Directors.
Mocco will offer insights into the strategic direction of the company as well as guidance on clinical strategies and new product development, the company said in a press release, as it seeks to bring its ProtEmbo cerebral protection system to market.
Protembis has recently received US Food and Drug Administration (FDA) approval to conduct an investigational device exemption (IDE) study aimed at demonstrating safety and efficacy of the ProtEmbo system during transcatheter aortic valve implantation (TAVR).
The ProtEmbo system is an intra-aortic filter device that protects the entire brain from embolic material liberated during the TAVI procedure. It is a low-profile system that shields all cerebral vessels, delivered through the left radial artery for optimal placement and stability, the company’s press release adds.
The IDE study is designed as a multicentre randomised controlled trial in the USA and Europe.
Mocco brings a wealth of clinical and academic experience as the Kalmon D Post professor and senior vice chair of the Department of Neurological Surgery at Mount Sinai and is the immediate past president of the Society of Neurointerventional Surgery (SNIS). In a career spanning more than 20 years, he has authorship credits on over 600 publications, and is an editorial board member of Stroke since 2015 as well as serving as an associate editor of other journals including Neurosurgery, the Journal of Neurointerventional Surgery, and ISNR Stroke.
“I have been impressed by the Protembis team’s achievements in developing an elegant system to mitigate cerebral infarction risk during TAVI,” Mocco is quoted as saying in the press release. “Their adaptive IDE clinical trial strategy is both rigorous and innovative. I am excited to offer my insights and guidance to the Board as this field evolves to treat future aortic stenosis patients who will have zero tolerance for brain injury as a potential procedural complication”.
“To have such an eminent expert with deep experience in the field of stroke joining our Board, is a strong indication of the Protembis solution for cerebral embolic protection’s impact in the future of TAVI,” said Karl von Mangoldt and Conrad Rasmus, co-CEOs of Protembis.
