Indian medtech maker Meril Life Sciences has won regulatory approval for a transcatheter aortic valve replacement (TAVR) developed exclusively in India, according to a published report.
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’s website.
India’s Central Drugs Standard Control Organisation granted the MyVal device approval for commercialization last month, according to a report on moneycontrol.com. In addition to the valve, Meril (Vapi, Gujarat, India) developed the entire minimally invasive technology to place it in the heart, the report says.
“All patients are doing well post procedure and during follow-up,” the company said in a statement reported by MoneyControl. “This novel Myval technology is associated with Zero new pacemaker implantation rates post procedure which is an important benefit for the patient already treated for valve replacement.”
Medtronic (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) dominate the TAVR industry. In October, Edwards (Irvine, Calif.) launched a U.S.-based pivotal trial of its self-expanding Centera transcatheter aortic valve, exploring its use in treating severe symptomatic aortic stenosis in intermediate risk patients. The previous month, Fridley, Minn.-based Medtronic announced the launch of a study of its CoreValve Evolut replacement heart valve in a low-risk patient population with a genetic form of heart disease, following a pair of FDA decisions about the treatment.