FDA Grants Green Signal to Protembis for Pivotal Investigational Device Exemption (IDE) Study

Friday, October 20, 2023

Protembis GmbH, a privately-owned emerging company in the field of cardiovascular medical devices, has disclosed the FDA's approval of the PROTEMBO Pivotal IDE Trial (NCT05873816). This pivotal trial is slated to enroll a cohort of 250-500 randomly selected patients undergoing Transcatheter Aortic Valve Replacement (TAVR) procedures in the United States and Europe. The trial aims to assess the efficacy of ProtEmbo's next-generation 3-vessel cerebral artery protection system compared to a hybrid control group. The control group will be divided into two equal parts, with one group not receiving Cerebral Embolic Protection (CEP) and the other receiving the Sentinel CEP from Boston Scientific, which safeguards only two of the three cerebral arteries originating from the aortic arch.

The primary efficacy endpoint will be evaluated using Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) and will employ an innovative adaptive statistical approach that includes pre-specified interim analyses with the potential for early termination if the new system proves to be superior. The primary safety endpoint will assess the rate of major adverse cardiac and cerebrovascular events (MACCE) at the 30-day mark, with neurological events being evaluated by stroke neurologists. The significant advancements in this initiative can be attributed to the collaborative efforts of the Global Steering Committee, the clinical research organization, and core lab partners who diligently strategized this intricate trial.

In the same dedicated CEP session, preceding this update, Dr. Tobias Schmidt from Luebeck, Germany, will present exploratory secondary endpoint data from the ProtEmbo-C trial using DW-MRI. To round out Protembis's scientific program, Dr. Felix Hofmann from Giessen, Germany, will deliver a Challenging Case presentation during the TCT Masters Session.


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