Filterlex Medical Ltd., a cardiovascular medical device startup, announced today that it has completed its CAPTIS First-In-Human (FIH) study. Study results will be presented by Prof. Ran Kornowski, Director of the Cardiology Center at Rabin Medical Center during the EuroPCR conference, 17-20 May, 2022.
The CAPTIS is a next-generation, full-body embolic protection device to reduce the risk of stroke and other complications during left-heart procedures.
The FIH study was designed to demonstrate the safety and feasibility of the CAPTIS device in patients undergoing Transcatheter Aortic Valve Replacement (TAVR). The study, including 20 patients, took place in two leading hospitals in Israel, Wolfson Medical Center and Rabin Medical Center (Beilinson Hospital).
During catheter-based procedures, such as TAVR, embolic particles are often released into the blood stream and may cause neurological deficiencies, extending from cognitive impairment to debilitating stroke.
The CAPTIS device is easily and intuitively deployed and retrieved. It is securely positioned in the aorta, protecting its surface, while facilitating a seamless TAVR procedure. The CAPTIS uniquely requires no additional arterial access and does not interfere with the procedure workflow.
“The unique design of the CAPTIS was created out of a deep understanding of the TAVR procedure and commitment to protect patients’ brain and kidneys. We look forward to presenting these promising FIH results later this month,” said Co-founder and CMO, Dr. Giora Weisz.
Sigal Eli, Filterlex Medical Co-founder and CEO added: “We are thrilled about having reached this milestone. With our recent successful US $6 million series A1 investment and €7 million investment commitment from the European Innovation Council, our strategic plan is being executed and we remain committed to delivering a much-needed embolic protection device to the millions at risk during TAVR.”
Filterlex Medical Ltd. is a cardiovascular medical device startup developing the CAPTIS®, a full-body embolic protection device. In 2016, Filterlex joined Alon MedTech Ventures incubator, owned by Dr. Shimon Eckhouse, a leading entrepreneur and investor in the field of medical devices. The company’s founders have vast clinical knowledge and extensive experience in medical device development, commercialization, and marketing.