Meril Life Sciences announced in December 2010 CE mark approval for the Biomime sirolimus-eluting stent.
The company was started in 2007 and has since then developed a novel concept in creating a low injury coronary stent system which allows for superior conformability and early endothelialisation thereby demonstrating high safety and efficacy. Meril’s primary design platform has been the CE approved NexGen Cobalt Chromium (L605) alloy stent which has good acceptance in various markets since 2008. Built on sound NexGen stent technology, Meril has successfully developed a new generation drug-eluting stent, the BioMime sirolimus-eluting coronary stent system.
Stent induced arterial injury is an important determinant of restenosis. Platelet deposition, thrombus formation and smooth muscle cell proliferation begin in response to arterial injury. Stent implantation imparts extreme vascular strain and focal mechanical injury to the vessel wall. The amount of injury inflicted by the stent and balloon is a function of stent-balloon geometry. Literature over the past decade has demonstrated that low strut thickness of a stent allows for low injury during angioplasty and superior conformability allows for early endothelialisation. These result into favourable clinical outcomes. In that light BioMime Sirolimus Eluting Coronary Stent comes as a fresh thought in taking stents towards biomimicry concept.
The stent is built on an ultra-low strut thickness (65µm) cobalt chromium stent platform, using an intelligent hybrid of close and open cells allowing for morphology mediated expansion, employs a well known anti-proliferative – sirolimus that elutes in 30 days and a biodegradable co-polymer formulation that ensures high coating integrity and low coating thickness of 2µm. The resultant stent demonstrates almost 100% endothelialisation at 30 days in pre-clinical model.
Subsequent clinical trials conducted in India went on to prove that BioMime has exceptional scientific basis with demonstrable clinical evidence.
Clinical trials include a single, de-novo, non-complex lesion study involving 30 patients. Here BioMime demonstrates high safety of 0% major adverse cardiac events and 0% stent thrombosis at one year while maintaining a high efficacy standard of 0.15mm late luminal loss at eight months QCA and 0% binary restenosis or target lesion (TLR) or target vessel revascularisation (TVR).
In a larger study involving 250 patients, conducted in 12 high volume operating centres across India, multivessel disease with varied lesion morphologies were treated with BioMime. Roll-in phase data reveal similar safety and efficacy data. Major adverse cardiac events were found to be 2.6% (0.87% non-cardiac death and 1.7% TLR). This study reports a high efficacy of 0.18mm late luminal loss at eight months QCA.
Moving ahead from BioMime, the group has now invented its own anti-proliferative agent – Merilimus (a third generation sirolimus analogue) and has developed a thinner stent – Mitsu, which maintains 40µm strut thickness. The drug is released via nanotechnology based solid-lipid formulation to deliver the anti-proliferative. Mitsu will soon undergo pre-clinicals and later first in man with an objective of entering the US coronary stent market.