Following the approval, the US-based EnCompass Technologies plans to immediately start clinical site start-up activities in patients undergoing TAVR
EnCompass Technologies has received the conditional Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) of its F2 cerebral embolic protection (CEP) system, to enable the launch of a US pilot study.
The F2 CEP system is an embolic filtration device that filters most emboli produced during cardiovascular procedures, thereby preventing them to reach the brain while preserving blood flow.
Following the approval, the US-based EnCompass Technologies plans to immediately start clinical site start-up activities in patients undergoing transcatheter aortic valve replacement (TAVR).
The F2 filter is said to be only filter with smallest average pore size among all CEP devices at 30µm.
EnCompass Technologies’ F2 system, positioned in the aortic arch, is intended to ensure 360-degree wall apposition, thereby preventing any migration.
The cerebral embolic protection system is simple to implant, deploy, and retrieve as it is connected to a self-expanding nitinol stent, the medical device company said.
EnCompass Technologies CEO George Wallace said: “Brain injury after TAVR, as well as other cardiovascular procedures, remains a significant problem. As most of these complications are caused by emboli, it makes sense to use a filter that blocks most harmful emboli from entering the brain.
“The US pilot study, along with our growing clinical experience outside the US, represents the beginning of our clinical journey towards demonstrating meaningful patient benefits.”
Recently, researchers from University of California, Los Angeles (UCLA) compared the F2 CEP device against Boston Scientific’s Sentinel in an in vitro study.
The F2 filter effectively blocked 94% more emboli than Sentinel did for all sizes, EnCompass Technologies claimed.
As part of a first-in-human trial that started in April this year, three patients receiving TAVR in Tbilisi, Georgia, US, were given the F2 filter. The patients showed complete procedural success and no negative outcomes.
A similar pilot project started in Australia this month and the medical device firm is planning to start a key clinical study in the US in 2024.