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Vascular Concepts' stent undergoing clinical trials

P.T. Jyothi Datta

Mumbai , Feb. 9

AWAY from the global attention on Indian drug companies, fledgling Bangalore-based medical devices company Vascular Concepts is undertaking the clinical trial of its innovative stent, coated with a combination of two drugs.

The Rs 35-crore company has embarked on a multi-centre clinical trial in Germany on its combination-drug-eluting stent and 20 patients have been enrolled since December last year, said Mr Swaminathan M. Jayaraman, Chief Executive Officer of Vascular Concepts.

Stents are thin steel wires inserted into blood vessels to remove blockages and drug-coated stents prevent the blockages from recurring. While these are increasingly becoming popular in treating heart-related ailments, Vascular Concepts is trying out an innovation on its stent, with a combination of two drugs — Sirolimus, an immuno-suppressant and Cyclosporine an anti-infective.

About 200 more people will be enrolled on the trials, Mr Jayaraman told Business Line and added that the enrolment would be closed by June. The trials were primarily for heart-related application, but secondary usage in the neck-vessels, legs and renal arteries would also be tested. He expected the results to be out by December.

Highlighting the significance of the product, he said that at present there were no combination-drug-coated stents available in the global market.

Besides targeting the Indian market, the company is preparing for commercial entry into the European market, he said. Sales in Europe with the existing portfolio of stents are expected to start around the second half of this year. Vascular Concepts has a manufacturing collaboration with Germany's Eucatech AG, where the former's products are made.

Meanwhile, the company is looking at raising resources for its foray into Europe, besides supporting the clinical trials. A decision on the multiple options being considered by it would be taken in the next three months, the CEO said.

Stents continue to be prohibitively priced in the Indian market, industry representatives said, with the dominating players being Johnson and Johnson and Boston Scientific. Further, they observed, stents in the domestic market are priced at over Rs 1 lakh, pushing them out of reach for a number of patients who cannot afford them. Vascular Concepts' stents are priced at about 25 per cent less, Mr Jayaraman said.

About plans for the US market, he said the company would develop a niche product, a micro-mash stent for the market. These stents would be used in below the knee applications. But cracking the US is still some time away, he added.

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