The study was designed to analyse the safety and feasibility of the CAPTIS device in patients undergoing Transcatheter Aortic Valve Replacement (TAVR)
FIH study investigators and team after successful completion of the first CAPTIS patient procedure at the Rabin Medical Center. (Credit: PRNewswire/ Filterlex Medical Ltd.)
Israel-based cardiovascular medical device firm Filterlex Medical has completed First-In-Human (FIH) study for its CAPTIS full-body embolic protection device.
The CAPTIS is a next-generation full-body embolic protection device used during left-heart surgeries to lower the risk of stroke and other problems.
The study was designed to analyse the safety and feasibility of the device in patients undergoing Transcatheter Aortic Valve Replacement (TAVR).
It included 20 patients and was carried out at Wolfson Medical Center and Rabin Medical Center in Israel (Beilinson Hospital).
Filterlex Medical said that embolic particles are discharged into the bloodstream during catheter-based treatments like TAVR, and they can induce neurological problems like cognitive impairment to catastrophic stroke.
According to the firm, the CAPTIS device can be deployed and recovered quickly and simply. It is implanted in the aorta, preserving its surface while allowing for a smooth TAVR surgery.
It does not require extra artery access and does not disrupt the procedure flow.
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: “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.”
Rabin Medical Center’s cardiology centre director Ran Kornowski will present the CAPTIS study results at the EuroPCR conference, which will be held from 17-20 May 2022.
In November last year, Filterlex Medical completed a $6m Series A1 investment round from private healthcare investors to accelerate the study of the CAPTIS device.