EnCompass F2 Cerebral Embolic Filter for TAVR Used in First Procedures

June 2, 2023—EnCompass Technologies, Inc. recently announced the first use of its novel F2 cerebral embolic filter. The device was used successfully in three transcatheter aortic valve replacement (TAVR) procedures on April 29th and 30th at the Israeli-Georgian Medical Research Clinic in Tbilisi, Georgia. EnCompass Technologies is based in Carson City, Nevada.

In the pilot clinical trial, Irakli Gogorishvili, MD, who is Head of Interventional Cardiology at the Israeli-Georgian Medical Research Clinic, partnered with Tamim Nazif, MD, and Isaac George, MD, both of Columbia University in New York, New York.

According to the company, all three patients received the F2 filter percutaneously before TAVR. No complications were observed, and all patients recovered without clinical evidence of brain injury. Further, on diffusion-weighted MRI performed within the first 48 hours of the procedure, the efficacy of the EnCompass F2 filter to reduce particulate debris to the brain was strongly suggested.

“The F2 filter was relatively easy to insert, deploy, and retrieve. Its position remained stable throughout the procedure, despite passage of wires and large catheters. Clearly, the early results are encouraging,” commented Dr. George in the company’s press release.

EnCompass Technologies stated that its F2 filter offers micropore filtration that 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.

The company noted that before this pilot clinical trial, a study led by Naoki Kaneko, MD, at the University of California Los Angeles showed the F2 filter dramatically reduced the burden of cerebral microemboli in a benchtop simulation compared to the market-leading filter. EnCompass advised that it plans for the F2 filter to undergo further clinical testing before becoming available for widespread use.