Meril gets CE mark for transcatheter heart valve

June 11, 2019 0 By FM

Meril Life Sciences has received CE certification Myval – transcatheter heart valve (THV) system.

The CE certification would enable Myval -THV to reach over 60 countries in Europe and outside of India which accept CE mark document for their own regulatory approvals.

The Myval THV System has a hybrid honeycomb 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 THV gets crimped on a navigator delivery system which comes with a dual-stopper system ensuring valve crimping is precise. The Myval System includes 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 THV.

Meril is the first Indian company to market and distribute its indigenously designed and patented TAVR technology, the company said in a statement.

Meril Life Sciences got CE and Central Drugs Standard Control Organization (CDSCO) approval for Myval 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.

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 in). The TAVR procedure is also beneficial for treating patients with previously failed bioprosthetic valve, hence preventing an additional surgical intervention.