EnCompass Technologies, Inc., a privately held medical device company focused on protecting patients from brain injury during cardiovascular procedures, announced its novel F2 cerebral embolic filter was used successfully in three transcatheter aortic valve replacement (TAVR) procedures on April 29th and 30th at the Israeli-Georgian Medical Research Clinic, Tbilisi, Georgia.
TAVR is a less invasive cardiac procedure that treats patients with severe aortic stenosis without open heart surgery. While TAVR represents a major advance for patients, it carries a small but significant risk of brain injury, including stroke. Brain injury after cardiac procedures, including TAVR, afflicts nearly one million patients globally each year. The primary cause is particulate debris released during instrumentation that blocks blood flow to the brain.
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EnCompass Technologies, a US-based medical device company, has developed a novel filter device to deflect debris away from the brain, thereby reducing the risk of brain injury. The F2 filter offers important advantages over previous embolic protection devices, such as best-in-class micropore filtration that further reduces the size and volume of embolic debris reaching the brain, full coverage of all three great vessels supplying the brain, and stability throughout the TAVR procedure.
Prior to the pilot clinical trial, a study was conducted at the University of California Los Angeles led by Naoki Kaneko, MD. The F2 filter was shown to dramatically reduce the burden of cerebral microemboli in a benchtop simulation compared to the market leading filter.
“The EnCompass F2 filter was designed with pores small enough to trap most harmful debris while preserving blood flow to the brain, and the UCLA study results show it is doing precisely what it was designed for,” said George Wallace, CEO of EnCompass.
SOURCE: PR Newswire