Human trial on new heart stent to start in India

Hyderabad, Dec 09: Human trials on eluting and non-elutingcoronary stent with a bioactive nano-structured carbon-carbon compositecoating with pro-healing properties will start in India January 2007and the first commercial version was likely to be released in themarket by May 2008.

The first stent implant was to be taken up at a Corporate hospitalhere in Janaury next and by February 2007 it will be across eightCentres in India, including Narayana Hrudalaya, All India Institute ofMedical Sciences, PGI Chandigarh and Sanjay Gandhi Heart ResearchInstitute.

A Multi Centre Clinical Trial with 15 International Centres andcovering 2000 patients in India to evaluate both Non-eluting as well asthe Drug-Eluting Stents of Relisys, a Hyderabad-based medical devicemanufacturer, is likely to release the human trial data by December2007.

India's first stent is likely to be commercialised by mid-2008,Relisys Medical Device Limited Managing Director N G Badri Narayan toldthe newspersons here today.

The new stent consists of a Cobalt-Chromium Stent coated with aporous carbon-carbon composite nano-structured matrix with a surfacedesign for improved endothelialisation.

The company which planned to invest Rs 40 crore on its stentproject, including Rs 12 crore on human trials expects to marketIndia's first indigenous stent with German technology at almost halfthe price of its competitors in the International market.

The company also announced that its existing Licence and SupplyAgreement with CINVENTION, the German technology company focusing onnano-composite material in biomedical applications for marketing ofeluting and non-eluting coronary stent had been extended.

Relisys will additionally focus on receiving a CE mark for itsnon-eluting stent during the next year 2007 and subsequently directlyentering the US market with the non-eluting stent.

UNI