Cardiovascular disease is the leading cause of death in India since the 1990s. Over the last few decades, there have been multiple studies showing that the number of deaths caused by heart disease has only gone up since then. Recognising the need of the hour, Meril Life Sciences is the first Indian Medtech company to receive CE approval for the Myval Transcatheter Heart Valve and also for creating the world’s first 100 micron thin-strut bioresorbable vascular scaffold. As we continue to make headlines for these contributions to Medtech, let’s take a closer look at how our products reduce discomfort for patients and why we will continue making headlines that make our country proud.
What we did
A heart attack generally occurs when the flow of blood to your heart is blocked. This blockage is caused by a buildup of fat, cholesterol and other substances which form a clot inside your heart and disrupt blood flow. A popular method of treating this blockage is through the use of stents. A stent is a small mesh tube placed inside these blocked arteries. These stents then expand along with your aortic valve and help you restore regular blood flow. The drawback to this solution was that the stents available in the market were metallic stents, which, along with aiding recovery would also remain inside the heart as a permanent metal implant. Mr. Sanjeev Bhatt, Vice President Corporate Strategy, Meril Life Sciences, addressed this concern by explaining the MeRes 100 scaffold in further detail. He explained that the MeRes 100 uses a polymer with 100-micron thickness, which is almost half the width of a human hair. This ultra-thin scaffold is made from a polymer known as polylactide and is used to deliver drug-eluting stents that release medication to treat the blocked artery. This polymer not only releases medication into your arteries, they also fully degrade in 2-3 years, thus allowing the artery to heal naturally over time without further surgery.
How we did it
While the answer may seem simple now, 5 years ago, the question facing Dr. P.K Minocha, Director of Research at Meril Life Sciences looked as daunting as any. Is it possible to create a thinner strut stent, made of a polymer that degrades in three years, while still retaining the strength to fulfill its purpose of healing a blocked artery? To answer this question, the team working on the project ended up studying over 180 combinations of various polymers to narrow down their search to 12 desirable combinations. Work began by selecting one proprietary polymer blend as the material for this scaffold. Over 235,000 man-hours, coupled with millions of dollars of investment resulted in 18,000 prototypes, produced at various stages of development and bench testing. This is how they finally arrived at the now patented ultra-thin, bioresorbable stent.
The final obstacle
Even after the product had been created there was one final obstacle in the way, the safety and efficacy of this next-generation fully biodegradable scaffold had yet to be proven clinically. Various trials and clinical studies took place all across India, Brazil, Europe and Asia. Leading cardiologists from India and all across the world participated in these clinical studies. The first-year data from these studies showed zero scaffold thrombosis and virtually 100% strut coverage. These results stayed consistent over a testing period of about three years.
When we set out to create the next-generation biodegradable stent, which would benefit patients by strengthening their heart valve, the chances of success were slim. Apart from the wide array of medical devices which provide access to affordable and world-class healthcare for patients, the MeRes 100 and the Myval studies prove that Indian companies can not only produce world-class technology but can also innovate and advance patient care on a global scale. Staying true to our core tenet of adding more to life, Meril Life Sciences will continue to innovate and create new headlines to make India proud in the future.
Comments
Post a Comment