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Meril Life Sciences Receives CE Marking For Bioresorbable Scaffold Stent

Meril Life Sciences has announced that its indigenously designed and manufactured scaffold -MeRes100 BRS becomes the first thin-strut bioresorbable scaffold to receive CE marking

Headquartered in Vapi, Gujarat, Meril is a global medical device company that manufactures a wide array of medical solutions like vascular intervention devices, orthopaedic implants, in-vitro diagnostics, endo-surgery and ENT products.

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.

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% to 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.

“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 of Fortis Escorts Heart Institute in New Delhi, India.

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. (August 9, 2019)

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