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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 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 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 deployment.

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

Other News

Telangana Govt Allocates 250 Acres Of Land For Medical Device Park At Sultanpur
Phillips-Medisize Showcases Drug Delivery Innovations For Indian Market
Tekni-Plex Completes Acquisition Of Amcor Flexible Packaging Units Serving Medical Device OEMs





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