Jaipur, 10
March, 2021.
Meril Life Sciences today announced the launch of its
indigenously researched and developed bioresorbable scaffold (BRS) MeRes100 in
India. Bioresorbable scaffolds are non-metallic, non-permanent mesh tubes,
similar to stents, that dissolve over time after ensuring the previously
blocked artery is opened via a routine angioplasty procedure. This novel
therapy option, which can meaningfully treat an identified subset of the
patient population, will be launched in a phased, sequential manner to ensure
adherence to best clinical practices and continued development of clinical
research and long-term evidence.
Currently, MeRes100 is being launched in 16 cities across
India, including Mumbai, Delhi, Gurgaon, Bangalore, Chennai, Pune, Hyderabad,
Ahmedabad, Lucknow, Chandigarh, Mohali, Jaipur, Kochi and Eddakad (in Kerala),
Nagpur and Bhubaneswar.
Sanjeev Bhatt, Sr. Vice President, Corporate Strategy,
Meril Life Sciences, commented, “We are committed to
introduce MeRes100 BRS in India and ensure it is delivered to the right
patients in line with the right indication. We will ensure sequential hospital
roll-out to facilitate best clinical practices, appoint a team of trained
clinical specialists to assist cases and conduct doctor education on protocols
for successful bioresorbable stent implantation. Through these measures, we aim
to facilitate the best outcomes for patients.”
He continued, “Moreover, in support of long-term research
on BRS therapy, we will facilitate a multi-national, multi-centre, randomized clinical
trial, MeRethon RCT, comparing MeRes100 to conventional drug eluting stents.
Approximately 2,000 patients will undergo clinical, angiographic and OCT
imaging follow-ups over five years, to establish long term clinical evidence of
BRS therapy and its benefits. Meril Life Sciences will also convene a BRS
clinical forum with national and international experts to continuously update
each other on best practices for optimal patient outcomes.”
MeRes100 is the first-ever 100 micron thin-strut BRS
developed to treat people with coronary artery disease. Till date, it has been
granted a total of 12 patents from USA, Japan, Australia, Russia,
Europe, Korea, China, Brazil and India. Backed by multi-year safety and
efficacy data from Indian and international trials, MeRes100 has received DCGI
approval as well as European CE approval. These trials include MeRes-1, led by
principal investigator Dr. Ashok Seth, leading Indian interventional
cardiologist and Chairman, Fortis Escorts Heart Institute, which validated the
benefits of using next-generation thin-strut technology.
Cardiovascular diseases (CVDs) such as coronary heart
disease are the leading cause of mortality in India. The prevalence rate of
coronary heart disease in young Indian men is twice that of those in western
nations. Further, there is evidence to suggest CVDs begin to affect Indians at
least a decade earlier than Europeans.
Dr. Sanjeeb Roy, Director- Cardiology, Fortis Escorts
Hospital, Jaipur, commented,
“There is a growing need for innovation-driven solutions to cater to specific
unmet patient needs while demonstrating sustained safety and efficacy outcomes.
In India, there has been a shift in the age groups affected by coronary artery
disease, with younger patients being diagnosed, often as a result of unhealthy
or stressful lifestyle patterns. The older cohorts with cardiac disease also
present a unique set of challenges, including recurrent lesions in the same
arterial location and hesitancy regarding permanent implantations.
Bioresorbable scaffolds pose a next-generation solution that caters to these
patients, leveraging technology and innovation to open blockages and deliver
the drug to facilitate healing over the horizon of treatment, while dissolving
naturally after healing is completed.”