Meril’s MyValMarch 5, 2019
Vapi never figured in India’s science hotspots until now. But this small industrial town in Gujarat—predominantly a chemical manufacturing hub on the Maharashtra border, has started attracting young scientific talent in the biomedical engineering field, thanks to the unrelenting medical technology research and development efforts of a company that made India proud of late.
The country’s first indigenous Transcatheter Aortic Heart Valve Replacement (TAVR) device, an important milestone that made the Indian med-tech industry proud, was successfully developed in this tiny town.
Meril Life Sciences, the Vapi-based med-tech company received approval for launching its indigenous TAVR technology— Myval THV—from the Central Drugs Standard Control Organisation (CDSCO) in October. With this, Meril has become the first Indian company in the world to make this technology commercially available, promising to give long-established multinational brands tough competition.
TAVR, an established treatment modality for patients who are at a high risk or unwilling to undergo open heart valve replacement surgery, is a minimally invasive procedure in which the doctor inserts a replacement valve into the patient’s native diseased valve via a catheter inserted through the femoral artery. This is an alternative way to replace diseased valves without undergoing the traditional open heart procedure, which some patients may not tolerate. The market for transcatheter aortic valve implantation (TAVI), which is growing rapidly with the increasing cases of aortic valve stenosis, has so far been catered to by multinational med-tech giants such as the US-based Edwards Lifesciences and Medtronic, Ireland.
Long and passionate effort
Meril has been working on this project for the last six years. Though its 150 strong R&D team at the Vapi campus has had several other firsts to their credit, including a completely indigenous ultra-thin strut bio-degradable polymer-based Sirolimus DES—BioMime in 2010, a thin-strut Sirolimus eluting bioresorbable vascular scaffold — MeRes 100 in 2016, Myval is one of their most prestigious projects.
“Since its inception, Meril has played a leading role in developing and introducing innovative medical technologies. The TAVR technology has been developed after 6 years of extensive research and is backed by robust bench testing, pre-clinical and clinical data. We are committed to take this technology to over 100 countries and benefit thousands of patients across the globe,” says Dr P K Minocha, director, Research & Development, Meril Life Sciences.
The launch of the indigenously developed transcatheter heart valve is an assertion of the company’s fundamental belief that it will focus on novel, clinically relevant and best-in-class devices to alleviate human suffering and improve quality of life, according to Meril’s senior management.
“Meril has always been dedicated towards design and development of novel, clinically relevant and best-in-class devices to alleviate human suffering and improve quality of life.
For us, it is a proud moment to be the first Indian company to commercially make this therapy available in the country,” says Sanjeev Bhatt, vice president, Corporate Strategy, Meril Life Sciences.
The regulatory approval for Myval came after successful completion of extensive clinical studies in India.
“All the patients are doing well post Myval procedure and during follow-up,” says a confident Bhatt.
The product demonstrates that it is possible to develop such a complex medical device completely in India by Indian scientists.
“We have not outsourced the technology and it’s fully developed here in this campus and within our own means. And more importantly, the innovation that we could bring in its design is clinically significant as compared to all existing technologies,” Bhatt said in an interview with Future Medicine.
Because of its unique design, the product sits at the annulus in a precise manner, Bhatt said. It therefore prevents leakage, known as paravalvular leakage (PVL), associated with the implantation of a prosthetic heart valve, whether using a traditional (surgical) or transcatheter (TAVI) approach.
Secondly, this design is also associated with zero new pacemaker implantation rates post procedure, which is an important benefit for the patient already treated for valve replacement. This is because its precise placement mechanism doesn’t excite the conduction system. Since the tolerance at this zone is minimum, only a precise deployment of the device can avoid exciting the system. In the current genre of devices, usually there are upto double digit rates of needing new permanent pacemakers.
A study published in the Journal of American College Cardiology (JACC) in 2016 found that patients who undergo minimally invasive heart valve replacement, typically a TAVR, sometimes develop heart rhythm problems that necessitate the placement of a permanent pacemaker. However, when a new pacemaker is needed soon after TAVR procedure, patients often have worse outcomes than those who do not need a pacemaker. The study, based for the JACC report, also showed that such risks are both short- and long-term and include lengthier stays at hospital and intensive care units as well as a greater risk of death.
“For us, it is a proud moment to be the first Indian company to commercially make this therapy available in the country. Through the commercialisation of this technology, Meril will soon bring a next-generation treatment modality to thousands of patients globally, making India proud of this achievement,” claims Bhatt.
According to him, Meril realises that if it has to do very complex science in areas where no alternatives exist at the moment, it has to be in keeping with its primary philosophy of identifying an unmet need and then providing its whole infrastructure, knowhow, talent and even the training for doctors by becoming a perfect facilitator of that new concept and technology.
Although the critics say that the Indian devise was built on the existing technology platform that is already available in the market, Meril argues that every novel design has been developed by improvising existing platforms, which is a fact everywhere in the world and India is not an exception.
But the ultimate merit of this indigenous technology depends on the response that it receives from the cardiac surgeons in the country.
“We have found Myval to be safe and easy to use in the initial series of procedures. But a longer follow up data will be needed to study the long term durability and cardiovascular outcomes, though the cost has been proved advantageous,” said Dr Hisham Ahmed, a senior cardiac surgeon at Amrutha Institute of Medical Sciences, Kochi, whose team has implanted Myval in four patients so far.
Aortic valve stenosis is one of the most prevalent heart diseases globally and the number of cases at any conservative estimate would cross 3 to 3.5 per cent of the elderly population. Currently available estimates show that more than 1 million cases of aortic stenosis are diagnosed per year in India alone, mainly due to age related degradation of the aortic valve—an important cause not only in India but in other parts of the world as well. Although less invasive procedure to replace the valve is the much sought after treatment today, the number of such procedures is comparatively less in India due to cost and access issues. Indigenous technology and more awareness can bring in more volumes and counter pricing and affordability issues.
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