November 18, 2019
Thirty-Day Data Presented for MyVal-1
November 18, 2019—Meril Life Sciences Pvt. Ltd. announced that 1-month data from the MyVal-1 clinical trial demonstrated safety and high procedural success rates. MyVal-1 is a first-in-human, prospective, multicenter, single-arm, open-label study of the company’s Myval transcatheter heart valve (THV) for the treatment of severe symptomatic aortic valve stenosis in patients with intermediate- to high-risk for surgical aortic valve replacement.
Coprincipal Investigator Ravinder Singh Rao, MD, Director of TAVR and Structural Heart Disease at Eternal Heart Care Centre and Research Institute in Jaipur, India, presented the data at the annual congress of PCR London Valves, held November 17–19, 2019, in London, United Kingdom.
The Myval THV system, which received CE Mark approval earlier this year, is a balloon-expandable THV. It has a hybrid honeycomb cell design, with open cells toward the aortic end to ensure unjailing of the coronary ostia and closed cells toward the ventricular end for radial strength. The device is also equipped with an internal polyethylene terephthalate (PET) sealing cuff for lower profile and sealing resistance and an external PET buffing to minimize paravalvular leaks, noted Meril.
According to Meril, the trial—which enrolled 100 patients and will follow-up out to 5 years—demonstrated a high procedural success rate and a high survival rate, with low incidence of stroke and a low rate of new permanent pacemaker implantation postprocedure at 30 days. The company noted that the precise orthotopic valve positioning with the Myval for transcatheter aortic valve repair (TAVR) contributed to the trial’s success at 30 days.
At PCR London Valves, Dr. Rao highlighted an improvement in quality of life at 1 month, measured by the 6-minute walk test and the Kansas City Cardiomyopathy Questionnaire, as well as an improvement in New York Heart Association functional class.
“The direct crimping of the Myval THV balloon has made my TAVR procedures simple and intuitive. Availability of intermediate sizes is a huge step in minimizing patient-prosthetic mismatch. Now, we can size the prosthetic valve to the patient and not the other way around. Moreover, the ability to deliver all diameters from 20 to 29 mm via a low-profile, 14-F, expandable introducer sheath has a profound impact in lowering vascular complications,” commented Dr. Rao in the company’s announcement. “I am enthusiastic about the excellent clinical and hemodynamic outcomes we have achieved at 30 days in the cohort of patients enrolled.”