Meril Life Sciences to receive CE marking for 100 micron Bioresorbable Scaffold
MeRes100 is a next generation thin-strut bioresorbable scaffold which is indigenously designed
Meril Life Sciences has announced that MeRes100 BRS, its indigenously designed and manufactured scaffold, became the first thin-strut bioresorbable scaffold to receive CE marking. Meril’s MeRes100 has received both DCGI and CE (European Conformity) marketing approval. Backed by rigorous research and encouraging clinical trial data, MeRes100 is planned to be launched in various countries, including European countries, later this year.
Cardiovascular diseases (CVDs) such as coronary artery disease are the biggest cause of mortality in India and there is evidence that CVD begins to affect Indians at least a decade earlier than it affects Europeans. 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. 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, 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.
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 endothelialization and healing, resulting in lower risk of scaffold thrombosis. Both trials have also validated this benefit, by demonstrating zero scaffold thrombosis and very low major adverse cardiac event (MACE) rate of 1.87% with MeRes100 BRS in MeRes-1 Study at three years and 1.61% MACE in MeRes-1 Extend Study at two years.