Meril Life Sciences, a global device maker recently launched India’s first artificial heart valve technology called Myval. The Transcatheter Aortic Heart Valve Replacement is also known as TAVR in short is a minimally invasive procedure in which the doctor places an artificial valve into the patient’s diseased valve via a catheter inserted through the femoral artery. The device will be marketed under the name of Myval. The company received the approval from Indian drug regulator Central Drugs Standard Control Organization (CDSCO) for commercialisation of Transcatheter Aortic Heart Valve Replacement.

With the launch of the artificial heart valve technology, Meril became the first Indian company in India to make this technology commercially available. The development of this valve, which is implanted non-surgically through a catheter has also been touted as a an achievement for the ‘Made in India’ initiative as it is a important R&D innovation that has happened from India in a field, which till now was by only American devices.

Extremely impressed with MERIL, an Indian bio medical device Co which has designed, innovated & developed over 100 clinically relevant, state of the art & best in class products for the global markets. Amazing company based in Vapi ! pic.twitter.com/m91yw3st32

— Amitabh Kant (@amitabhk87) April 12, 2018

“For us, it is a proud moment to be the first Indian company to commercially make this therapy available in the country. Through the commercialization of this technology, Meril will soon bring the next generation treatment modality to thousands of patients across the country and globally. Making India proud of this achievement,” said Sanjeev Bhatt, Vice President-Corporate Strategy, Meril Life Sciences in a press statement.

What Is MyVal And How Will It Function ?

Myval is indigenously developed and manufactured artificial aortic valve that regulates the blood flow in the heart. Earlier valves were made of metal and plastic, but slowly much safer tissue valve have come in and this is the area where Meril decided to catch-up with the advancements.
The company had developed a bioprosthetic heart valve from pericardial materials of bovine and porcine sources. Making a valve isn’t enough, the company also developed balloon delivery system, entire paraphernalia around accessories system along with primary treatment protocols.

Around 150 engineers of Meril R&D team worked to develop this TAVR technology.

• Meril had not just developed the valve but the entire technology to replace the valve through a minimally invasive surgery on the lines of angioplasty.
• It is an established treatment modality for patients who are at a high risk or unwilling to undergo open heart valve replacement surgery.
• This is an alternative way to replace diseased valves without undergoing traditional open-heart procedure which some patients may usually not tolerate well.

“The Myval-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,” said Dr. P K Minocha, Director, Research & Development, Meril Life Sciences.

5 Major Advantages Of Myval –

• The cost of TAVR surgery is estimated anywhere between INR 5,00,000 – 600,000 Myval TAVR technology will be a boon for millions of patients suffering from aortic stenosis as the price of the technology will be well within the reach of common man.
• TAVR is a preferred alternative for surgical valve replacement because it is associated with faster recovery time
  The 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.
• The valve is effective in relieving the patient’s symptoms and reducing the death and hospitalisation from the aortic stenosis.
• In India, less than 200 procedures are done in a year, but the patients who need TAVR in India could be around 300,000, so now more patients will be able to access the advanced cardiac care.

Myval’s Viability & Regulatory Approvals –

• According to Ravinder Singh Rao, Interventional Cardiologist at Eternal, the viability of this technology is such that the first patient to receive Myval has completed 1.5 years and is living a symptom-free productive life.
• No major adverse cardiac, cerebral and renal events has been observed at six months follow-up and zero mortality among the patients in the trial.
• According to Dr Ashok Seth, Chairman of Fortis Escorts Heart Institute, the Myval-TAVR technology has been developed after six years of extensive research and is backed by robust bench testing, pre-clinical and clinical data.
• The technology also has got approval from the Indian drug regulator Central Drugs Standard Control Organisation (CDSCO) for its commercialisation.
• The approval is based on successful results from a clinical trial done in India, involving 14 hospitals majorly Fortis and Medanta-The Medicity and Eternal Hospital, Jaipur.