The FIH clinical study principal investigators, Professor Haim Danenberg and Professor Ran Kornowski, celebrate successful completion of the first CAPTIS patient procedure with their team. Credit: Filterlex Medical / PRNewswire.

Israel-based cardiovascular medical device start-up Filterlex Medical has completed the first-in-human (FIH) study of its CAPTIS device.

A next-generation, full-body embolic protection device, CAPTIS is designed to lessen the risk of stroke and other complications during catheter-based heart surgeries.

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The study was designed to evaluate the safety and feasibility of the CAPTIS device in patients undergoing Transcatheter Aortic Valve Replacement (TAVR).

According to Filterlex, embolic particles often get released into the bloodstream during TAVR procedures. This may create neurological deficiencies in the patient, ranging from cognitive impairment to debilitating stroke.

The CAPTIS device can be placed in the aorta to preserve its surface while ensuring a seamless TAVR procedure.

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Additionally, the device does not require additional arterial access or impact the procedure workflow.

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The FIH study was conducted in two locations, specifically the Israel- Wolfson Medical Center and Rabin Medical Center (Beilinson Hospital), and included 20 patients.

The results will be presented during the EuroPCR conference, scheduled later this month.

Filterlex Medical co-founder and CMO Dr Giora Weisz said: “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.”

Filterlex Medical co-founder and CEO Sigal Eli said: “With our recent successful $6m series A1 investment and €7m 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.”