Protembis Announces FDA Approval of its Pivotal Investigational Device Exemption (IDE) Study

October 19, 2023 |

3 min read

Protembis GmbH a privately-held emerging cardiovascular medical device company, announced the FDA has approved the PROTEMBO Pivotal IDE Trial.

Novel Adaptive Superiority Trial Design of ProtEmbo^® Cerebral Embolic Protection (CEP) System

AACHEN, Germany--(BUSINESS WIRE)-- Protembis GmbH (Protembis) a privately-held emerging cardiovascular medical device company, announced today the FDA has approved the PROTEMBO Pivotal IDE Trial (NCT05873816). The trial will recruit between 250-500 randomized patients undergoing TAVR in the USA and Europe with the next generation ProtEmbo’s complete 3-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, USA), 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.” Says Dr Roxana Mehran (Mount Sinai, New York) Chair of the Study Executive Committee. The trial will be led by Dr Susheel Kodali (New York Presbyterian Hospital, NYC), Dr Raj Makkar (Cedars Sinai, Los Angeles) and Dr Stephan Haussig (Dresden Herzzentrum, Dresden, Germany), as the designated Global Co-Principal Investigators.

“We are delighted to announce that the pivotal IDE trial has been approved by the US 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,” said Karl von Mangoldt and Conrad Rasmus Co-CEOs of Protembis.

In addition, Protembis has announced the acceptance of three ProtEmbo related presentations for the upcoming TCT Congress in San Francisco, USA (October 23-26). Firstly, the results of the ProtEmbo-C European CE-Mark clinical trial will be presented by Dr Darren Mylotte (Galway, Ireland). “On behalf of the ProtEmbo-C investigators, I am proud to present the final data, which demonstrates that ProtEmbo has the potential to offer a next generation device that is safe and intuitive. It covers all three cerebral vessels without interaction with the TAVR systems by leveraging a very low profile in the aortic arch with a robust anchoring mechanism, and it significantly reduces large clinically meaningful new cerebral lesions,” says Dr Mylotte.

This presentation will be preceded, in the same dedicated CEP session, by the exploratory secondary endpoint DW-MRI data of the ProtEmbo-C trial presented by Dr Tobias Schmidt (Luebeck, Germany). Finally, to round out the scientific program for Protembis, there will be a Challenging Case presentation during the TCT Masters Session by Dr Felix Hofmann (Giessen, Germany) demonstrating the use of ProtEmbo to protect the brain of a patient who underwent a procedure to remove mitral vegetation.

About ProtEmbo and Protembis

The ProtEmbo System is an intra-aortic filter device that protects the entire 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.

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.