Through the deal, the companies will provide Venus Medtech’s transcatheter aortic valve replacement system along with Keystone’s TriGuard cerebral embolic protection device.
TriGuard is a cerebral embolic protection device designed to reduce the amount of embolic material entering blood circulation to the brain during TAVR procedures, by allowing blood to pass through while catching potentially dangerous embolic debris.
“Providing brain protection for every TAVR patient will differentiate Venus Medtech and position them as a leader in structural heart therapies – underscoring its dedication to excellence and focus on patient safety. This partnership provides us the opportunity to make an impact in the fast growing structural heart space in an extraordinarily important geographic market,” Keystone Heart prez & CEO Chris Richardson said in a press release.
Venus Medtech said that it is hopeful that its TAVR device will be the 1st device approved by China’s Food and Drug Adminstration for marketing in the region.
“It is of utmost importance to us that our devices improve the quality life of the patients whom receive them. Our transcatheter heart valve systems offer patients life-saving support — and collaborating with Keystone Heart allows us the opportunity to reduce the risk of brain injury during the procedure. No other company offers this combination,” Venus Medtech prez & CEO Eric Zi said in a prepared statement.
Last September, Keystone Heart released data from TAVR patients treated with its TriGuard cerebral embolic protection device, touting a significant reduction in brain lesions.
Preliminary results from a real-world study of 51 patients who underwent TAVR procedures were presented at the PCR London Valves 2016 Conference, Keystone Heart said. Patients treated with the TriGuard embolic deflection device showed a 20% rate of new brain lesion developments, compared with 68% for patients treated without the TriGuard, Keystone Heart said.
No strokes were reported during the study and there was a 100% rate of successful device placement, the company said. The MRI arm of the study reported a “clear improvement” in the mean number of new lesions, mean total lesion time and mean single lesion volume for patients treated with TriGuard.