Filterlex Medical’s Captis Embolic Protection Device for TAVR Evaluated in First-in-Human Study

November 15, 2023—Filterlex Medical Ltd., a cardiovascular medical device startup based in Israel, announced the publication of a first-in-human (FIH) study of the safety and feasibility of the company’s next-generation Captis full-body embolic protection device during transcatheter aortic valve replacement (TAVR) procedures.

According to Filterlex Medical, the FIH study was composed of 20 patients undergoing TAVR procedures with the Captis device. There was a 100% success rate in the use of th&e device, and TAVR procedures were completed with no device-related complications or cerebrovascular events. The findings were published by Haim D. Danenberg, MD, et al online in EuroIntervention.

The Captis system captured a high number of embolic debris particles, showing promise in providing embolic protection and enhancing safety during TAVR, stated the company.

Filterlex Medical advised it continues to pursue the development and clinical investigation of the Captis device, aiming to substantiate its use in TAVR and other left heart procedures.

Giora Weisz, MD, CMO of Filterlex Medical, commented in the press release, “The positive outcomes and strong performance of the Captis device in a clinical setting showcased in the EuroIntervention publication are indeed encouraging. This study sheds light on the capability of the Captis device to deliver neurovascular and systemic embolic protection, crucial for lowering the risk of stroke and other embolic events during TAVR procedures. It also highlights its promise for improving patient outcomes in other complex cardiac procedures.”