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.
http://pharmabiz.com/NewsDetails.aspx?aid=117436&sid=1 (August 9, 2019)