Three Patients Successfully Underwent TAVR While Using F2 Embolic Filter Device From EnCompass Technologies

World's First Use of EnCompass Medical Device to Protect Against Brain Injury Achieved at the Israeli-Georgian Medical Research Clinic, Tbilisi, Georgia

CARSON CITY, Nev. -- 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 year1. The primary cause is particulate debris released during instrumentation that blocks blood flow to the brain.

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.

In the pilot clinical trial, Irakli Gogorishvili, MD, Ph.D., 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 City. All three patients received the F2 filter percutaneously before TAVR. No complications were observed and all recovered without clinical evidence of brain injury. Further, on diffusion-weighted magnetic resonance imaging (DW-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," said Isaac George, MD.

EnCompass plans for the F2 filter to undergo further clinical testing before becoming available for widespread use, however, the strong positive signal from the world's first use demonstrates promise for all patients who undergo TAVR globally each year.

About EnCompass Technologies

EnCompass Technologies, Inc. is a privately held medical device company based in Carson City, Nevada. The company is focused on the development of embolic filtration devices that protect patients from brain injury during cardiovascular procedures. F2 is not commercially available and is intended for investigational use only.

References

1. Wolman, R. L., Nussmeier, N. A., Aggarwal, A., et al. Cerebral injury after Cardiac Surgery. Stroke, 30(3), 514–522. https://doi.org/10.1161/01.str.30.3.51

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