Lancet. 2008 Sep 27;372(9644):1163-73. Epub 2008 Aug 31.

Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial.

Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Jüni P.

Department of Cardiology, and CTU Bern, Bern University Hospital, Bern, Switzerland. stephan.windecker@insel.ch

Comment in:

• Lancet. 2008 Sep 27;372(9644):1126-8.

PMID: 18765162 [PubMed - indexed for MEDLINE]

A new competitor for Biosensors  as well as J & J - Meril Life Sciences has just got CE mark approval for their Sirolimus drug eluting stent, with a biodegradable co-polymer, AND WITH only two small clinical trial, with one study comprising of only 30 patients and a larger study comprising of 250 patients.

For info.

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 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 NexGenTM Cobalt Chromium (L605) alloy stent which has good acceptance in various markets since 2008. Built on sound NexGenTM stent technology, Meril has successfully developed a new generation DES – BioMimeTM Sirolimus Eluting Coronary Stent System which is now CE approved.

 

Stent induced arterial injury is an important determinant of restenosis. Platelet deposition, thrombus formation & smooth muscle cell proliferation begin in response to arterial injury. Stent implantation imparts extreme vascular strain & focal mechanical injury to the vessel wall. The amount of injury inflicted by the stent & 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 favorable clinical outcomes.

 

In that light BioMimeTM 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 30days and a biodegradable co-polymer formulation that ensures high coating integrity and low coating thickness of 2µm. The resultant stent demonstrates almost 100% endothelialization at 30days 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% 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 Revascularisation (TVR).

 

In a larger study involving 250 patients, conducted in 12 high volume operating centers across India, multi-vessel disease with varied lesion morphologies were treated with BioMime. Roll-in phase data reveal similar safety and efficacy data. Major adverse cardiac events (MACE) 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 8months QCA.

 

Moving ahead from BioMime, the group has now invented its own anti-proliferative agent – Merilimus (a 3rd generation sirolimus analogue) and has developed a thinner stent - MitsuTM which maintains 40µm strut thickness. The drug is released via nano-technology 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.

 

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