CII, AMTZ Join Hands To Help Usher In Business Opportunities
For MSMEs Towards Indigenous Manufacturing
The Confederation of Indian Industry (CII) in association with Andhra Pradesh
MedTech Zone Ltd (AMTZ) helped over 80 Indian MSMEs related to healthcare and
medical devices to understand best manufacturing practices and local supply
chain management towards the central government’s Make in India initiative.
Medical device manufacturers and other MSMEs recently congregated at AMTZ
Visakhaptnam campus to understand the mutual need for supporting operations
towards possible business opportunities as part of the session titled “Business
Opportunities for Healthcare and Medical Devices for MSMEs”.
Over the years, CII has worked closely with government and industry to raise the
competitiveness of Indian MSMEs and escalate the productivity levels of each
sub-sector through adoption and dissemination of best practices, knowledge
management systems and appropriate technologies.
Meril’s Myval Transcatheter Heart Valve
Receives CE Approval
Meril Life Sciences becomes the first and currently only Indian company to
market and distribute its patented Transcatheter Heart Valve (THV): MyvalTM -THV
System to Europe and other countries.
Recently, MyvalTM received the coveted CE approval. Meril now becomes the first
Indian company to market and distribute its indigenously designed and patented
TAVR technology, MyvalTM -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
MyvalTM -THV to reach over 60 countries in Europe and outside of India which
accept CE mark document for their own regulatory
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 MyvalTM 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
MyvalTM THV gets crimped on a Navigator delivery system which comes with a
dual-stopper system ensuring valve crimping is precise and snug. The MyvalTM
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 MyvalTM THV.
Meril Life Sciences got CE and Central Drugs Standard Control Organization (CDSCO)
approval for MyvalTM 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