Human trial on heart stent to start in India

Hyderabad, Dec 9: Human trials on eluting and non-eluting coronary stent with a bioactive nano-structured carbon-carbon composite coating with pro-healing properties will start in India January 2007 and the first commercial version was likely to be released in the market by May 2008.

The first stent implant was to be taken up at a Corporate hospital here in Janaury next and by February 2007 it will be across eight Centres in India, including Narayana Hrudalaya, All India Institute of Medical Sciences, PGI Chandigarh and Sanjay Gandhi Heart Research Institute.

A Multi Centre Clinical Trial with 15 International Centres and covering 2000 patients in India to evaluate both Non-eluting as well as the Drug-Eluting Stents of Relisys, a Hyderabad-based medical device manufacturer, is likely to release the human trial data by December 2007.

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

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

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

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

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

UNI