- Data on 100 patients treated with Meril's Myval Transcatheter Heart Valve (THV) for severe symptomatic aortic valve stenosis demonstrated high safety and effectiveness at one-month in MyVal-1 clinical trial
LONDON, Nov. 18, 2019 — A follow-up of 100 patients with intermediate- to high-risk for surgical aortic valve replacement (SAVR) in the MyVal-1 study demonstrated high procedural success rate. This is due to the precise orthotopic valve positioning with Meril's Myval THV System for Transcatheter Aortic Valve Replacement (TAVR). The device also demonstrated high survival rate with low incidence of stroke and low rate of new permanent pacemaker implantation post-procedure at 30 days, as reported at PCR London Valves 2019 (17-19 November 2019).
Data presenter and co-principal investigator Dr. Ravinder Singh Rao, Director TAVR and Structural Heart Disease at Eternal Heart Care Centre and Research Institute, Jaipur, India, also highlighted a significant improvement in patients' quality of life at one-month as measured by the six-minute walk test and the Kansas City Cardiomyopathy Questionnaire score. Furthermore, there was marked improvement in NYHA 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 minimising 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 – 29mm via a low profile 14Fr expandable introducer sheath has a profound impact in lowering vascular complications." said Dr Rao. "I am enthusiastic about the excellent clinical and haemodynamic outcomes we have achieved at 30 days in the cohort of patients enrolled."
The CE-approved Myval THV System is a balloon expandable transcatheter heart valve, made of Nickel Cobalt alloy frame. It has a unique, hybrid honeycomb cell design, with open cells towards the aortic end to ensure un-jailing of the coronary ostia and closed cells towards ventricular end for high radial strength. It is equipped with an internal PET sealing cuff for lower profile and puncture resistance and an external PET buffing to minimise paravalvular leaks.
"The currently available TAVR systems have established safety and effectiveness in eligible patients. However, accuracy in valve sizing and precision placement as well as accuracy in deployment, with conduction system abnormalities leading to new permanent pacemaker implantation, paravalvular regurgitation and vascular complications remain challenging in certain settings," said Sanjeev Bhatt, Vice President-Corporate Strategy, Meril. "Myval THV is a next-generation TAVR system which is intuitive, minimising physicians' learning curve and with promising clinical data that address most of these unmet needs."
MyVal-1 is a first-in-human, prospective, multicentre, single-arm, open label study of Myval THV in the treatment of severe symptomatic native aortic valve stenosis which enrolled 100 patients and will follow-up out to five years. The safety endpoint is survival at 30 days, six months and 12 months. Efficacy endpoints are improvement in NYHA class, effective orifice area and six-minute walk test, all at 30 days, six months and 12 months.
Founded in 2006, Meril is a global medical device company dedicated to innovate, design & develop novel, clinically relevant and state-of-the-art vascular intervention devices, orthopaedic implants, in-vitro diagnostics, endo-surgery and ENT products. Please visit https://www.merillife.com & www.myval.com. Follow Meril on LinkedIn here.
1. Rao R. The feasibility and safety of a balloon-expandable transcatheter heart valve: MyVal-1 study. Presented at PCR London Valves 2019