Indian medtech maker Meril Life Sciences said it has won the CE Mark for its MyVal-THV system, a transcatheter aortic valve replacement (TAVR) developed exclusively in India.
The MyVal device is balloon-expandable and employs a hybrid honeycomb cell design. The upper, open cells were designed to ensure un-jailing of coronary ostia, and the closed, lower cells offer high radial strength, according to the company.
One-year clinical outcomes from the MyVal-1 study showed 100% accurate procedural success and no device-related mortality, the company recently reported at EuroPCR. The study also showed no new pacemaker implantations, no strokes or paravalvular leaks observed. Echo parameters were maintained at 12-month follow-up and tests showed a significant increase in patient quality of life, the company said.
“We are excited by these results,” said Meril vice president of corporate strategy Sanjeev Bhatt in a news release. “Since its inception, Meril has played a leading role in developing and introducing innovative medical technologies. Our MyVal transcatheter heart valve technology is an assertion of this fundamental belief and after being granted the CE Mark, we get set to launch it across Europe. It’s a proud moment not just for us but for India to be able to make this indigenous innovation available globally.”