Meril last month received an approval from Indian drug regulator Central Drugs Standard Control Organization (CDSCO) for commercialisation of Transcatheter Aortic Heart Valve Replacement, which will be sold under the brand name Myval.
Meril Life Sciences, India's top medical device maker, is all set to launch an indigenously developed and manufactured artificial aortic valve that regulates the blood flow in the heart.
Meril last month received an approval from the Indian drug regulator Central Drugs Standard Control Organisation (CDSCO) for commercialisation of Transcatheter Aortic Heart Valve Replacement (TAVR), which will be sold under the brand name Myval.
Meril not just developed the valve but the entire technology to replace the valve through a minimally invasive surgery on the lines of angioplasty.
Headquartered in Vapi, Gujarat, India, the company got CDSCO nod on the basis of almost three years of clinical study in India.
"All patients are doing well post procedure and during follow-up. This novel Myval technology is associated with Zero new pacemaker implantation rates post procedure which is an important benefit for the patient already treated for valve replacement," Meril said.
Pacemaker is an additional device that may be placed post TAVR procedure.
Traditionally a degenerated aortic valve is replaced with artificial valve through an open heart surgery. However, open heart surgery requires longer hospitalisation, risk of infection and other side effects. Also, many patients typically need valve replacement at an old age, and may not be in a position to take the open heart route due other health issues. Meril's TAVR will solve that problem now.
To be sure this is no mean feat. With this launch, Meril will become the first Indian company in the world and the third in India to make this technology commercially available.
TAVR is dominated by US medical devices makers Medtronics and Edwards Lifesciences.
Edwards was the first company in the world to gain approval for a TAVR valve in the US.
Medtronic entered the TAVR market through its $700 million acquisition of CoreValve in 2009.
Meril makes wide array of implants and devices that includes cardiac stents, balloon catheters, orthopedic implants, intrauterine devices (IUD) for female contraception, and diagnostic devices among others. But the company derives over 50 percent of its revenues from selling stents and balloon catheters.
That segment is seeing an increasing competition from Indian and foreign stent makers, this was when Meril decided to move into much more complex technologies.
"Over the last six years we have consciously decided to move into structural heart diseases. Structural heart diseases are those where people have diseases not in the vessels, but in the heart itself," said Sanjeev Bhatt, vice-president (corporate strategy) at Meril.
Developing a TAVR from scratch isn't easy. Earlier valves were made of metal and plastic, but slowly much safer tissue valve have come in. Meril decided to catch-up with the advance. The company had developed a bio prosthetic heart valve from pericardial materials of bovine and porcine sources. Making a valve isn’t enough, the company developed balloon delivery system, entire paraphernalia around accessories system along with primary treatment protocols.
Bhatt said around 150 engineers of Meril R&D team have worked to develop the TAVR technology.
Huge untapped market
Currently less than 200 procedures are done in a year, but the patients who need TAVR in India could be around 300,000.
Bhatt says the opportunity is huge, but it requires sincere commitment from the device makers to educate patients and train doctors and paramedic staff to build required skills to expand the market.
With Ayushman Bharat, Bhatt expects more patients will be able to access the advanced cardiac care.
Bhatt declined to disclose the cost of the surgery.
"The idea is to make it within the reach of the patient," he said.Though hospitals don't provide a break up of TAVR surgery costs but it it estimated anywhere Rs 5,00,000- 600,000.