Financial Daily from THE HINDU group of publications
Friday, Aug 13, 2004
Financial Daily from THE HINDU group of publications Friday, Aug 13, 2004 |
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Corporate
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Announcements Industry & Economy - Health Boston Scientific recalls stents in India too P.T. Jyothi Datta
Mumbai , Aug. 12 MEDICAL devices company Boston Scientific Corporation has initiated a recall of specific batches of its drug-coated stents in India. The withdrawal follows Boston Scientific's recent global recall of the product due to its malfunctioning while being inserted into the arteries. Stents are thin steel wires inserted into blood vessels to remove blockages; drug-coated stents go one step further to prevent re-occurrence of the blockage, among other things, say medical professionals. "The company has recalled the specific batches of Taxus and Express 2 stents, but there is no reason for alarm. The product is safe; it is just a malfunctioning in the delivery system. There have not been any complaints in India and people on whom stents have been used need not worry about their safety. The re-supply of the product will happen in India once shipment resumes from the US," a company source told Business Line. The recall was being effected though the company's marketing network and by keeping doctors abreast of the activity. Taxus was launched in India in early 2003, around the time it was launched in Europe. And while no numbers were available on how many units have been shipped to India, the source said approximately 10,000 units had been used in India in the last 18 months. "The withdrawal of these stents in India has led to a shortage in the country since there are just two suppliers in this category: Johnson and Johnson and Vascular Concepts, a Bangalore-based company. And despite the high price (about Rs 1 lakh per unit), stents are increasingly gaining in popularity among doctors as a minimally-invasive technology," a healthcare industry representative told Business Line. Boston Scientific had initiated the global process of recall last month, when the company recalled the Taxus Express 2 stent due to problems related to the tiny balloon placed inside arteries to inflate the stent once it has been surgically moved into place, the sources said. According to news agency reports, Boston Scientific has shipped more than 500,000 Taxus stent systems and more than 600,000 Express 2 stent systems. Citing a Boston Scientific communiqué, the report said the company had received reports of one death and 18 serious injuries associated with balloon deflation for the Taxus stent system and two deaths and 25 serious injuries associated with balloon deflation in the Express 2. Significantly, Health Ministry sources said medical devices do not come under the direct purview of the Drugs and Cosmetics Act and hence the recall of the drug-eluting stent is a development they are not monitoring. However, as per the recommendations of the Mashelkar Committee report, there are plans to have a specific regulatory division governing medical devices," the official said.
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