Saturday, February 24, 2007


Stents for veins and arteries

Gauri Kamath

In April, five Indian hospitals are scheduled to begin a head-to-head comparison between the drug-coated stents of two leading manufacturers. The $11.4-billion Medtronic, a leading US medical devices company, will sponsor a global 8,000-patient trial over 200 centres in which India will also participate. The trial will compare Medtronic’s stent Endeavor with the $53-billion Johnson & Johnson’s Cypher, the market leader globally, and in India. A stent is a metal scaffold that is inserted into a clogged artery during balloon angioplasty to keep it open.

Drug-coated or medicated stents are a $6-billion business. A drug-coated stent is coated with medication that combats restenosis or reclogging of arteries, which occurs in roughly 30 per cent of the patients who have undergone balloon angioplasty using a bare stent.

But sales of drug-coated stents are under threat; they have recently been associated with clot-formation (called thrombosis in medical jargon) long after the surgery. This has led to a fall in sales for all major players including Medtronic. The trials are one way of dispelling the clouds of doubt around the product. “All stents were not created equal and we have not seen that sort of late stent thrombosis at least at an elevated level with our product,” claims Michael DeMane, senior vice-president and president (Europe, Canada, and emerging markets), Medtronic, who was on a visit to India. He stressed that drug-eluting stents “are good medicine”.

The trials will be on real-life patients as they walk into the clinic. Medtronic says it will not specify targets per hospital but will intervene if there is an imbalance — if there are too few or too many from any one area. Given the alarming rise of cardiovascular disease in India — it is the leading killer according to the World Health Organization — the results of the study should be of interest to doctors and patients here.

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