Meril’s Myval Transcatheter Heart Valve Receives CE Mark Approval
June 10, 2019—Meril Life Sciences Pvt. Ltd. recently announced it has received European CE Mark approval for the company's Myval transcatheter heart valve (THV) system for transcatheter aortic valve repair (TAVR) in the European Union and other international markets. However, the Myval THV system is not available for sale in France.
According to the company, the Myval THV system has a hybrid honeycomb design. Upon crimping, it has a distinct alternating dark-light banding pattern visible under fluoroscopy, which helps in precise placement of the valve and ensures orthotopic deployment.
Myval THV gets crimped on a Navigator delivery system that comes with a dual-stopper system ensuring valve crimping is precise and snug. The Myval system includes a low-profile (9-F) Mammoth balloon dilatation catheter for valvuloplasty. The kit also includes the low-profile (14-F) atraumatic, lubricious-coated Python introducer sheath, which allows for percutaneous access of the crimped Myval THV.
The company noted that 1-year clinical outcomes from the MyVal-1 study supported the initial regulatory approval by India's Central Drugs Standard Control Organization as well as the European CE Mark approval for the Myval THV.
The MyVal-1 findings, which demonstrated 100% acute procedural success and no device-related mortality, were presented by Ashok Seth, MD, the study's principal investigator, at EuroPCR held May 21–24 in Paris, France.
In the company's press release, Dr. Seth explained there were also no new pacemaker implantations, no strokes, and no paravalvular leaks observed in the trial patients. Additionally, echo parameters were maintained at 12-month follow-up and there was a significant improvement in the quality of life of the patients as demonstrated by tests including New York Heart Association functional class.