Cardiovascular data presented at EuroPCR 2022 demonstrates successful device performance during a TAVR procedure with no complications.
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).
The easily-deployed CAPTIS device is securely positioned in the aorta, protecting its surface, while facilitating a seamless TAVR procedure, without additional arterial access.
Prof. Haim Danenberg, Head of Interventional Cardiology at Wolfson Medical Center and the study 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 TAVR patients’ brain and kidneys.”
Prof. Ran Kornowski added, “I’m excited about the successful results in the FIH study and look forward to being part of future CAPTIS research.”
Sigal Eli, Filterlex Medical Co-founder and CEO added: “We are extremely encouraged by the study and will continue to build robust clinical evidence around the CAPTIS embolic protection device to support its use in TAVR.”