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Medical Devices Made With Tainted Heparin Recalled By Medtronic

Medtronic Inc. is recalling some medical devices because they may be coated with tainted heparin, a drug linked to 81 deaths in the US. The disposable medical devices, used during cardiac bypass surgery, are made with Medtronic's Carmeda BioActive surface, which includes heparin. No injuries have been reported in relation to the Medtronic devices, but the recall underscores the enormous scope of the problems involving contaminated heparin.

Tainted heparin first garnered attention earlier this year, when Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls by other manufacturers of Chinese-sourced heparin in 11 other countries, including Denmark, Italy, France Germany and Japan. In the US, heparin has been associated with the deaths of more than 100 people since early 2007, according to the Food & Drug Administration (FDA). Of those, the vast majority - 81 to be exact - were associated with contaminated batches of heparin.

In March, the FDA confirmed that it had found chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC. Since then, researchers have been able to show that chondroitin sulfate can cause reactions like those seen among patients treated with tainted heparin.

In speaking with reporters after a Senate hearing last month, FDA Commissioner Andrew von Eschenbach said that while the agency has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.” It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

Medtronic says the Carmeda BioActive surface is used on blood oxygenators, reservoirs, pumps and other disposable products that are used during the bypass surgery. According to Reuters, Medtronic initiated the recall because of an April 8 recommendation by the FDA that medical devices employing heparin be checked with newly-developed tests to make sure the heparin is not tainted. Chondroitin sulfate cannot be identified with the tests normally used to inspect batches of heparin.

A separate Medtronic line of disposable bypass-surgery products covered with a different biosurface called Trillium will remain on the market because they incorporate far smaller amounts of heparin.

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Italy-India Forum Focuses On Technology Co-operation

Italian Trade Commission (ICE), in association with Federation of Indian Chambers of Commerce and Industry (FICCI), recently organised Italy-India fora at New Delhi and Bangalore. The focus was on co-operation in the form of technology transfer between enterprises, research centres, realisation of joint training projects, and exchange between universities through scholarships. The enlisted speakers discussed exchange of intellectual property with particular reference to the emerging high technology sectors. ICE also came out with special reports on biotechnology and nanotechnology sectors in India.

Paolo Trichilo, Charge 'd'Affaires a.i., Embassy of Italy, said, "This forum is an important step in promoting trade relations between the two countries and I am thankful to FICCI for helping us organize the same. India is gradually making a mark in the biotechnology sector and by 2010, the Indian biotech industry is expected to achieve revenue of $5 million and create one million jobs. The forum was to encourage Italian representatives to develop a better understanding of Indian biotechnology and nanotechnology, improve economic co-operation between the two countries in form of technology transfers."

Professor Leonardo Santi, President, National Committee for Biosafety, Biotechnology and Life Sciences, Italy, while addressing the gathering said, "Italy in agreement with EU believes that biotechnology and life sciences are to be considered priority for any country's economy. With India experiencing a moment of great economic growth, thanks to organisational and social instruments with specific features, can ensure harmonic collaborations in the field of bio economy."


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