Meril Life Sciences becomes India’s first to receive CE marking for 100 micron Bioresorbable Scaffold

Meril Life Sciences has announced that its 100 micron Bioresorbable Scaffold (MeRes100 BRS) became the first thin-strut bioresorbable scaffold to receive CE marking. It has received approval from DCGI and CE (European Conformity) marketing and is expected to be launched in various countries later this year.

Cardiovascular diseases (CVDs) like coronary artery disease are the biggest cause of mortality in India and there is an evidence that CVD begins to affect Indians at least a decade earlier than it affects Europeans. Also, stents are widely accepted as a primary intervention for treating coronary artery disease and associated lesions or blockages due to fat deposition and plaque formation.

Across clinical trials, 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 positive safety and sustained efficacy outcomes for patients with coronary artery disease in treatment of de-novo coronary artery lesions. Its proprietary hybrid-cell design has optimal strut thickness and improved crossing profile for better deliverability. The scaffold strut thickness is 100 microns, which leads to faster endothelialisation and healing, resulting in lower risk of scaffold thrombosis.

A long-term three-year follow-up data of the MeRes-1 study, published in EuroIntervention, which includes a combination of clinical follow-ups as well as angiographic and intravascular imaging demonstrated the high efficacy of MeRes100 at two years with low late lumen loss (0.24±0.34mm), virtually complete strut coverage (99.24 per cent) and sustained mean flow area with very low percentage volume obstruction (7.5 per cent).

The data was recently presented by Co-principal Investigator of MeRes-1 Study, Dr Praveen Chandra, Chairman, Interventional Cardiology, Medanta – The Medicity, Gurugram, who commented, “The cumulative major adverse cardiac event (MACE) rate, which includes cardiac death, heart attack, and Ischemia-driven TLR/ repeat procedures, 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 at 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” said Principal Investigator for the MeRes-1 trial Dr Ashok Seth, Chairman, Fortis Escorts Heart Institute, Delhi.

“Intensive research and development efforts exerted by 150 scientists, chemists, engineers and researchers at Meril’s research facilities in Vapi, Gujarat over five years have culminated to multiple regulatory approvals and over seven patents. This is the first time three-year data of a next generation thin strut BRS has been presented in the world with consistency in safety and efficacy (zero per cent stent thrombosis and low MACE rate of 1.87 per cent– a truly

proud moment for Meril Life Sciences,” said Sanjeev Bhatt, Vice President-Corporate Strategy, Meril Life Sciences.

Metallic drug eluting stents (DES) 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: on an

average, two to three per cent of patients with metallic DES implants may require a repeat intervention year on year.