Vapi-based Meril Life Sciences has become the first Indian company to receive European Conformity (CE) marking for its 100 micron bioresorbable scaffold (BRS), or dissolvable polymer stents. The company will soon make it available across various countries later this year.
The product MeRes100, a next generation thin-strut BRS, has been designed and manufactured using technology developed by Meril Life Sciences at its facility in Vapi, Gujarat. The product, backed by research and clinical trial data, has received both Drug Controller General of India and CE marketing approvals.
Sanjeev Bhatt, vice president-corporate strategy, Meril Life Sciences, told The Hindu that metallic drug eluting stents (DES), which are in use as a primary intervention for treating coronary artery disease and associated lesions or blockages due to fat deposition and plaque formation, have a metallic platform with drug coating. “The role of a DES is to provide temporary scaffolding to the blockage or lesion site and also to deliver a drug to facilitate healing. After healing is complete, the metallic stent remains in the body as a permanent implant. Such metallic DES are associated with incremental risk of clinical or adverse events,” Mr. Bhatt said.
Meril said its 100 micron BRS was a result of intensive research and development efforts by 150 scientists, chemists, engineers and researchers at its research facilities in Vapi over five years, which have got it multiple regulatory approvals and over seven patents.
Data collated by Meril shows that on an average, 2-3% of patients with metallic DES implants may require a repeat intervention year on year. “MeRes100 was designed as a solution to bridge this gap between the temporary treatment horizon for opening a blockage and the undesirably permanent nature of a metallic DES implant,” Mr. Bhatt said.
Through MeRes-1, the first in-human study conducted in India and MeRes-1 Extend, conducted in Brazil, Europe and Asia, MeRes100 BRS has shown long-term safety and sustained efficacy for patients with coronary artery disease. The proprietary hybrid-cell design of MeRes100 ensures better deliverability. The scaffold strut thickness is 100 microns, which leads to faster healing, resulting in lower risk of scaffold thrombosis, Mr. Bhatt said. Both trials had also validated this benefit, he said.
Dr. Praveen Chandra, chairman of interventional cardiology at Medanta – The Medicity, Gurgaon, who was co-principal investigator of MeRes-1 Study observed that the cumulative major adverse cardiac event rate, which includes cardiac death or heart attack, is better at three years for MeRes100 as compared to previous generation BRS technology.
“First generation bioresorbable scaffolds have not shown the most favourable results in long-term horizons. The next generation bioresorbable scaffold with reduced strut thickness, improved profile for better deliverability, faster degradation and possibly lower scaffold thrombosis is a revolutionary advance in interventional cardiology,” principal investigator for the MeRes-1 trial Dr. Ashok Seth, chairman of Fortis Escorts Heart Institute, New Delhi, said.
(The writer was in Vapi at the invitation of Meril Life Sciences)