Filterlex Medical Announces Positive Results from A First-In-Human Study for the CAPTIS® Full-Body Embolic Protection Device
Caesarea, Israel, May 31st, 2022 – Filterlex Medical Ltd., a cardiovascular medical device startup, announced today results from a first-in-human (FIH) study demonstrating the safety, feasibility, and performance of the CAPTIS device. CAPTIS is a next-generation, full-body embolic protection device that reduces risk of stroke and other complications during left-heart procedures when embolic particles are released into the bloodstream.
Study data was presented at EuroPCR 2022 conference by Prof. Ran Kornowski, Director of the Cardiology Center at Rabin Medical Center in Israel.
The trial was a prospective, single-arm study involving 20 patients who underwent a successful Transcatheter Aortic Valve Replacement (TAVR) procedure while using the CAPTIS embolic protection device.
- 100% technical device performance success. The CAPTIS device was successfully deployed and retrieved in all patients, and the TAVR procedure was performed with no interference.
- There were no device related complications.
- No patients experienced cerebrovascular events (objectively examined by an independent neurologist).