Filterlex’s Captis Embolic Protection Device Evaluated With TAVR in FIH Study

May 31, 2022—Filterlex Medical Ltd., an Israel-based cardiovascular medical device startup, announced results from a first-in-human (FIH) study demonstrating the safety, feasibility, and performance of the Captis embolic protection device.

According to the company, the Captis FIH study is a prospective, single-arm study composed of 20 patients who underwent successful transcatheter aortic valve replacement (TAVR) while using the Captis device. The study’s Principal Investigator is Professor Haim Danenberg, MD, Head of Interventional Cardiology at Wolfson Medical Center in Holon, Israel.

The study data were presented at the EuroPCR 2022 conference held May 17-20 in Paris, France, by Professor Ran Kornowski, MD, who is Director of the Cardiology Center at Rabin Medical Center in Rabin Medical Center in Petah Tikva, Israel.

As summarized in the company’s press release, outcomes included the following:

• 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).

“I'm excited about the successful results in the FIH study and look forward to being part of future Captis research,” commented Prof. Kornowski in the company’s press release.

Prof. Danenberg added, “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.”

Captis is the company’s next-generation, full-body embolic protection device intended to reduce risk of stroke and other complications during left-heart procedures when embolic particles are released into the bloodstream. The device is designed to easily deploy and be securely positioned in the aorta, protecting its surface, while facilitating a seamless TAVR procedure, without additional arterial access, stated Filterlex.