Changes in design of Meril Life Sciences Myval Transcatheter Heart Valve approved by CDSCO panel
New Delhi: Approving the minor changes proposed by the Meril Life Sciences regarding the design of Myval Transcatheter Heart Valve (THV) and ballon catheter, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has asked Meril Life Sciences, an indigenous global medical devices company, to submit Post Marketing surveillance (PMS) data periodically to CDSCO for review.
Meril Life Sciences introduced the first ever indigenously designed and manufactured Transcatheter Aortic Heart Valve (TAVR) - Myval in 2018. The Myval TAVR technology had received approval for use by Central Drugs Standard Control Organization (CDSCO) on the basis of successful results from a clinical trial done in India.
With the launch, Meril, became the first Indian company to make Transcatheter Aortic Heart Valve Replacement (TAVR) Therapy commercially available on the world stage.
Myval THV is a newer-generation, balloon-expandable TAVR system with features that facilitate accurate positioning of the bioprosthetic valve and favorable procedural and clinical outcomes.
Also Read: Meril Launches Myval- Indigenously Developed TAVR Therapy In India
The recent nod to minor changes in the design of Myval Transcatheter Heart Valve (THV), came in response to the proposal presented by Meril Life Sciences for the same in order to increase the performance of the device.
After detailed deliberation, the committee recommended for approval of the proposed minor change in Myval transcatheter heart valve (model 1 and model 2) and ballon catheter medical device.
"The firm shall submit PMS data periodically to CDSCO for review," the panel noted.
