EnCompass Technologies has reported the successful utilisation of its new F2 cerebral embolic filter in three transcatheter aortic valve replacement (TAVR) surgeries.
These surgeries were performed last month at the Israeli-Georgian Medical Research Clinic in Tbilisi, Georgia.
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It marked the world’s first use of EnCompass’ medical device to protect against brain injury.
EnCompass created an innovative filter device to keep debris away from the brain, helping to lower the risk of brain injury.
The F2 filter provides significant improvements compared to earlier embolic protection devices, including complete coverage of all three major vessels supplying the brain and stability throughout the entire TAVR procedure.
It also offers better micropore filtration to further decrease the size and amount of embolic debris that can reach the brain.
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By GlobalDataEnCompass Technologies CEO George Wallace said: “The EnCompass F2filter 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.”
Dr Naoki Kaneko led a study with the filter, conducted at the University of California Los Angeles (UCLA) before the pilot clinical study.
In a benchtop simulation, the F2 filter significantly decreased the burden of cerebral microemboli, surpassing the performance of the leading filter in the market.
All three patients received percutaneous administration of the F2 filter before TAVR in the pilot clinical trial.
According to the company, no complications were reported and all the patients recovered without any signs of brain injury.
EnCompass aims to conduct further clinical testing on the F2 filter before making it widely accessible.
