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Meril Life Sciences' BioMime™ - Sirolimus Eluting Coronary Stent System receives CE approval
The first generation drug eluting stents (DES) initially demonstrated a good promise in terms of bringing down restenosis which was the bane of coronary stents. But over a period of time, the polymeric degradation by-products failed to bring about endothelialization. Failure in endothelialization gave rise to safety issues.
Currently DES technologies are targeted to minimize vascular injury during stenting using ultra-low strut thickness stents. Biodegradable polymer coatings are now gaining popularity and are in use to virtually eliminate inflammation, stent thrombosis and major adverse cardiac events while preserving the efficacy requirements of the DES.
In that light BioMimeTM Sirolimus Eluting Coronary Stent (now CE approved) comes as a fresh thought in taking stents towards biomimicry concept.
The base stent is made of Cobalt Chromium (L605) and has an ultra-low (65µm) strut thickness. Its novel design incorporates an intelligent mix of open and closed cells allowing for morphology mediated expansion of the stent. This hybrid stent has a high radial strength and comes pre-mounted on a flexible delivery system that maintains short-abrupt balloon shoulders to minimize balloon related edge injuries.
The entire stent surface is coated with a 2µm mix of known biodegradable polymers – Poly-L-Lactic acid (PLLA) and Poly-L-Glycolic acid (PLGA) along with the active anti-proliferative drug Sirolimus (1.25µg/mm2). The drug is timed to elute over a period of 30days, while the polymeric mixture degrades soon via hydrolysis and eventual elimination as CO2 & H2O.
Clinical trials include a single, de-novo, non-complex lesion study involving 30 patients. Here BioMime demonstrates high safety of 0% MACE and 0% stent thrombosis at 1 year while maintaining a high efficacy standard of 0.15mm late luminal loss at 8 months QCA and 0% binary restenosis or Target Lesion (TLR) or Target Vessel Revascularization (TVR).
In a larger study involving 250 real world patients, roll-in phase data reveal similar safety and efficacy. Major adverse cardiac events (MACE) were found to be 2.6% (0.87% non-cardiac death and 1.7% TLR).
Moving ahead from BioMime, Meril Life Sciences has now invented its own anti-proliferative agent - Merilimus (a 3rd generation sirolimus analogue) and has developed a 40µm strut thickness stent - MitsuTM. The drug is released via nano-technology based solid-lipid formulation. Mitsu will soon undergo pre-clinicals and later first-in-man with an objective of entering the US coronary stent market.
Meril Life Sciences is a young, dynamic medical device development and manufacturing company based in India at Vapi (150kms north of Mumbai). www.merillife.com (You will be visiting a website outside of PCRonline, we are not responsible for its contents)
The company was established in 2006 and has been working on creating low injury coronary stent systems which allow for superior conformability, leading to early endothelialisation.
Meril’s current portfolio has the following product lines which are all locally approved and have CE mark-
- BioMime™ – Sirolimus Eluting Coronary Stent System
- NexGen™ – Cobalt Chromium Coronary Stent System
- Crypton™ – Stainless Steel Coronary Stent System
- Mozec™ – Rx PTCA Balloon Dilatation Catheter
- Haiku™ – Inflation Device
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