Meril’s Myval Transcatheter Heart Valve receives CE approval

6^th June 2019, Mumbai: Recently, Myval^TM received the coveted CE approval. Meril now becomes the first Indian company to market and distribute its indigenously designed and patented TAVR technology, Myval^TM -THV system, to European Union and other countries. The CE certification is a conformity mark indicating the product to be compliant with the European Union (EU) health standards. The CE certification would enable Myval^TM -THV to reach over 60 countries in Europe and outside of India which accept CE mark document for their own regulatory approvals.

TAVR is an established treatment modality for patients who are at a risk or unwilling to undergo open heart valve replacement surgery. TAVR is a minimally invasive procedure that repairs the aortic heart valve without removing the old, damaged valve. Instead, it places a replacement valve through a catheter or tube inserted through the femoral artery (the large artery in the groin). The TAVR procedure is also beneficial for treating patients with previous failed bioprosthetic valve, hence preventing an additional surgical intervention.

The Myval^TM THV System has a Hybrid honey comb design, on crimping it has a distinct alternating dark-light banding pattern visible under fluoroscopy. This unique pattern helps in precise placement of the valve and ensures orthotopic deployment. Myval^TM THV gets crimped on a Navigator delivery system which comes with a dual-stopper system ensuring valve crimping is precise and snug. The Myval^TM System includes Mammoth balloon dilatation catheter, 9F low profile, for valvuloplasty. The kit also includes atraumatic and lubricious coated Python introducer sheath, 14F low Profile which allows for percutaneous access of the crimped Myval^TM THV.

Meril Life Sciences got CE and Central Drugs Standard Control Organization (CDSCO) approval for Myval^TM technology basis the results of MyVal-1 Study. One-year clinical outcomes from the MyVal-1 study demonstrated 100% acute procedural success and no device-related mortality as reported at EuroPCR 2019 (21-24 May).

The data were presented in a Late-breaking trial session at EuroPCR’2019 Conference at Paris by the trial’s Principal investigator, Dr Ashok Seth, Chairman of Fortis Escorts Heart Institute, New Delhi, India.Dr Seth explained that in addition to the procedural success and zero device-related mortality rate, there were also no new pacemaker implantations, no strokes and no paravalvular leaks observed in the trial patients. Furthermore, Echo parameters were maintained at 12-month follow-up and there was a significant improvement in Quality of Life of the patients as demonstrated by tests including NYHA functional class.¹