EnCompass Technologies has announced its novel F2 cerebral embolic filter was used successfully in three transcatheter aortic valve implantation (TAVI) procedures at the Israeli-Georgian Medical Research Clinic, Tbilisi, Georgia.
While TAVI represents a major advance for patients, it carries a small but significant risk of brain injury, including stroke, and can be caused by 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 TAVI procedure, EnCompass Technologies said in a press release.
Prior to the pilot clinical trial, a study was conducted at the University of California Los Angeles (UCLA, Los Angeles, USA) led by Naoki Kaneko. 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, head of interventional cardiology at the Israeli-Georgian Medical Research Clinic, partnered with Tamim Nazif, and Isaac George, both of Columbia University (New York, USA). All three patients received the F2 filter percutaneously before TAVI. 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 company’s press release states.
“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 George.
EnCompass plans for the F2 filter to undergo further clinical testing before becoming available for widespread use.
