Filterlex Medical has announced the publication of a first-in-human (FIH) study EuroIntervention validating the safety and feasibility of the next generation Captis full-body embolic protection device during transcatheter aortic valve implantation (TAVI) procedures.
The risk of periprocedural stroke during TAVI is the result of calcified heart valve or tissue particles that break loose and travel in the bloodstream towards the brain. In the published study, the Captis system captured a high number of embolic debris particles, providing embolic protection and enhancing safety during TAVI procedures, the company said in a press release.
The study, which included 20 patients undergoing TAVI procedures with Captis, demonstrated a 100% success rate in the use of the device. TAVI procedures were completed with no device-related complications, and no cerebrovascular events.
Giora Weisz, CMO of Filterlex Medical, said: “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 TAVI procedures. It also highlights its promise for improving patient outcomes in other complex cardiac procedures.”
Filterlex Medical continues to pursue the development and clinical investigation of the Captis device, aiming to substantiate its use in TAVI and other left-heart procedures.