Meril has announced positive data on its Myval Transcatheter Heart Valve System at PCR London Valves 2019 (17–19 November 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. According to the press release, this is due to the precise orthotopic valve positioning with the Myval THV System for transcatheter aortic valve implantation (TAVI). 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.
Coprincipal investigator Ravinder Singh Rao (Eternal Heart Care Centre and Research Institute, Jaipur, India) presented the data and 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, as well as marked improvement in NYHA functional class.
Dr Rao states: “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. I am enthusiastic about the excellent clinical and haemodynamic outcomes we have achieved at 30 days in the cohort of patients enrolled.”
The statement explains that 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 unjailing 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.
Sanjeev Bhatt, vice president-corporate strategy at Meril, adds: “The currently available TAVI 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. Myval THV is a next-generation TAVI system which is intuitive, minimising physicians’ learning curve and with promising clinical data that address most of these unmet needs.”