Keystone Heart Ltd., of Caesarea, Israel and Tampa, Fla., scored a win in Europe after obtaining the CE mark for the Triguard 3 cerebral embolic protection (CEP) device. It is designed to minimize the risk of cerebral damage by deflecting embolic debris away from cerebral circulation during transcatheter aortic valve implantation (TAVI) and other transcatheter heart procedures. According to the company, the device is the only product with a CE mark designed to cover and protect all three major cerebral aortic arch vessels.

The Triguard 3 is placed via one of two femoral artery access ports typically used in transcatheter aortic valve replacement (TAVR), thereby eliminating the need for a third puncture site. It is designed to deploy quickly and self-position through a small 8F catheter, providing stable, atraumatic protection with simple retrieval.

Nicolas Dumonteil, an interventional cardiologist at the Clinique Pasteur in Toulouse, France, said that although clinicians have had increased experience with these procedures, and next-gen TAVI devices are available, cerebral complications remain a top concern. To that end, "[i]nterventional cardiologists are seeking options to avoid cerebral complications for their patients."

Keystone Heart is a part of Venus Medtech (Hangzhou) Inc., a Chinese transcatheter heart valve company. Venus reported in December 2018 that it had wrapped up its merger with Keystone Heart. Last summer, Venus applied for an IPO on the Hong Kong Stock Exchange, becoming the first pre-revenue med-tech player to aim at the bourse.

Chris Richardson, Keystone Heart president and CEO, told BioWorld that the company plans to enter all major European markets with the Triguard 3 CEP device during the second quarter. It also plans to file with the FDA in the same quarter. In addition to Europe and the U.S., the company is eyeing China and the Asia-Pacific.

Keystone Heart recently completed the pivotal REFLECT Trial and is finalizing data analysis ahead of the planned marketing application.

NICE questions CEP, authors see promise

At least one body of experts has had questions about using CEP devices. Specifically, the National Institute for Health and Care Excellence (NICE) in 2019 said using such devices does not eliminate the risk of embolic stroke after TAVI. Still, NICE acknowledged that there were no safety concerns over the risks of the procedure itself and called for additional evidence.

Months earlier, a paper, titled “Cerebral Embolic Protection In TAVI: Friend Or Foe,” appeared in the spring 2019 issue of Interventional Cardiology Review. The researchers concluded even though literature backs a drop in lesion volume and total lesion volume with the use of these devices, that has not meant a significant reduction in post-procedural or 30-day stroke and/or 30-day mortality. With that said, the authors saw promise in the technology, and refinements eventually could lead to a reduction in cerebral risk and neurocognitive function impairment.

Edwards, Boston Scientific

Edwards Lifesciences Corp. and Boston Scientific Corp. also are players in the cerebral protection space. Edwards obtained its device through the acquisition of Embrella Cardiovascular Inc., a deal that closed in early 2011. The purchase price was about $43 million cash.

The single-use, disposable Embrella device received the CE mark in May 2010.

For its part, Marlborough, Mass.-based Boston Scientific won its offering, the Sentinel cerebral embolic protection system, through its acquisition of Santa Rosa, Calif.-based Claret Medical Inc. in 2018. Claret won the FDA’s nod for its offering in 2017 via the de novo process.

Around the time of the FDA’s decision, Azin Parhizgar, then CEO of Claret, said her company’s product differed from the deflectors on the market, as it captured debris that go downstream.

During the Cowen Healthcare Conference March 3, Josh Jennings asked about Sentinel, noting that it appeared as if “cerebral protection enthusiasts are kind of winning the day, at least from my perception, going to these cardiology conferences.”

Susie Lisa, vice president of investor relations at Boston Scientific, noted that the company is enrolling in the Protected TAVR study to show that capturing and removing debris helps patients.

“There was … a retrospective observational study posted in JAMA last week that showed essentially equivalence between the two arms,” she added. “But I think interestingly enough, from a statistical perspective of equivalence, there were lower rates of stroke and devastating stroke and mortality in the Sentinel arm as well as more than a full day shorter length of stay, which is pretty compelling.”

For his part, Dan Brennan, executive vice president and CFO at Boston Scientific, had highlighted the product, noting it is growing in procedure volume and penetration in TAVR procedures.

Previously, during the Feb. 5 earnings call, CEO Mike Mahoney said that Sentinel was closing in on 20% of the overall U.S. TAVR procedural penetration, “and we believe definitive evidence focused on a stroke endpoint will continue to elevate Sentinel to become the standard of care for all patients and will help influence future clinical guidelines.”