Final data from European PROTEMBO C Trial Published in EuroIntervention Journal
New published European clinical evidence builds momentum for the FDA approved Pivotal PROTEMBO clinical trial.
Aachen, Germany, March 1, 2024
Protembis are proud to announce the publication of the final results from the European trial of the second generation ProtEmbo Cerebral Embolic Protection system. The study successfully demonstrated the safety of the system and its ability to reduce the burden of new cerebral lesions in patients undergoing Transcatheter Aortic Valve Replacement (TAVR) relative to historical data.
The study enrolled 64-patients and was run in 10 hospitals in Germany, Poland, and Latvia. Some key findings include:
- The incidence of MACCE in the enrolled population at 30-days was 4.7% (3/64), meeting the predefined Performance Goal (PG) for the primary safety endpoint (upper limit of 95% CI: 12.9% vs PG 25%; p=0.0001).
- Technical success was achieved in 95% of patients in whom the procedure was attempted (intention-to-treat population), achieving the predefined PG for the primary performance endpoint (lower limit of 95% CI: 86.3% vs PG 75.0%; p=0.0002).
- There were no patients who experienced a clinical stroke amongst those who received full procedural protection with ProtEmbo.
- Complete cerebral coverage was reported in 98.2% of patients; In the group of 51 patients who underwent baseline and acute follow-up Magnetic Resonance Imaging (MRI), 76.5% of patients were free of single lesions >150 mm³, and 94.1% were free of single lesions >350 mm³.
- The average time for device deployment was 4.7±4.4 minutes, and 84% of patients did not receive additional contrast for delivery of the ProtEmbo.
About Protembis
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 and has not yet been approved for commercial use by a regulatory authority.
Contact:
Protembis GmbH
Conrad Rasmus & Karl von Mangoldt
Co-CEOs & Co-Founders
+49(0)241 9903 3622
management[at]protembis.com
www.protembis.com