CE mark for Meril’s transcatheter heart valveAugust 5, 2019
Meril Life Sciences has received CE certification Myval – transcatheter heart valve (THV) system from the European Union.
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 distributes its indigenously designed and patented TAVR technology, the company said in a statement.