Embolic protection device presented at EuroPCR 2022
09 June 2022
Filterlex Medical has announced results from a first-in-human (FIH) study demonstrating the safety, feasibility, and performance of the Captis device, a full-body embolic protection device that reduces risk of stroke and other complications during left-heart procedures.
Study data by presented at EuroPCR 2022 (17–20 May, Paris, France) by Ran Kornowski (Rabin Medical Center, Tel Aviv, Israel). The trial was a prospective, single-arm study involving 20 patients who underwent a successful transcatheter aortic valve implantation (TAVI) procedure while using the Captis embolic protection device.
Key outcomes from the trial included 100% technical device performance success, with the Captis device having been successfully deployed and retrieved in all patients, and the TAVI procedure performed with no interference.
Kornowski also reported that there were no device related complications, and no patients experienced cerebrovascular events (objectively examined by an independent neurologist).
The Captis device is securely positioned in the aorta, protecting its surface, while facilitating a seamless TAVI procedure, without additional arterial access, Filterlex Medical detailed in a press release.
Haim Danenberg (Wolfson Medical Center, Holon, Israel) and the study’s principal investigator, said: “Safe and effective brain protection in percutaneous heart procedures is a true unmet need—I am very impressed with the promising Captis technology. Filterlex has developed an innovative solution that protects TAVI patients’ brain and kidneys.”
Kornowski added: “I am excited about the successful results in the FIH study and look forward to being part of future Captis research.”