Dive Brief:

• Keystone Heart, a unit of China’s Venus Medtech, said Tuesday it received a CE mark for use of its TriGuard 3 cerebral embolic protection device (EPD) to reduce stroke risk in patients undergoing transcatheter aortic valve implantation.
• The device works by deflecting embolic debris from the aortic valve and ascending aorta dislodged during the procedure before it can travel to the brain.
• The Israel-based company, which also has operations in Tampa, Florida, said it plans to pursue approval for the device in the U.S. and is now finalizing its clinical trial data analysis in preparation for submitting its marketing application to the FDA.

Dive Insight:

Keystone Heart will be looking to take on Boston Scientific, which has carved a niche for itself in embolic protection for valve replacement as the only device maker with a cerebral EPD on the U.S. market. That device, called Sentinel, received FDA De Novo clearance in 2017 before Boston acquired its maker, Claret Medical, for $220 million in 2018.

Boston Scientific CEO Mike Mahoney told investors last month that more than 600 U.S. hospitals are now using Sentinel. He estimated the device is being incorporated in as many as 1 in 5 U.S. transcatheter aortic valve replacement procedures, a market where Boston Scientific has a small foothold, but remains dominated by Edwards Lifesciences and Medtronic. Sentinel can be used in TAVR procedures in which a competitor’s valve is being implanted.

Although Boston Scientific has said it aims for use of EPDs to become standard across TAVR procedures, the company has run into skepticism from some in the cardiology community who question the impact of the devices in reducing stroke risk.

An analysis published in February in JAMA Internal Medicine found that among nearly 11,000 TAVR patients, there was no statistically significant difference in stroke rates between patients treated with the Sentinel device and those who did not get an EPD. In the 363-person Claret Medical-backed trial that supported FDA authorization of Sentinel, the device did not lower the risk of post-procedure stroke. But it did catch embolic debris in 99% of filters, and observational studies have pointed to benefits in using the device, the research letter said. 

Keystone Heart is looking to distinguish its device as the only cerebral embolism protection option that can cover all three aortic arch vessels leading to the brain. The compay recently completed the Reflect clinical trial, but results have not yet been published. The company’s Deflect III trial, which evaluated 85 patients and was completed in 2015, showed a 10% reduction in stroke among those treated with TriGuard, compared with patients who did not get the device.