FDA to Issue New Testing Requirements for Drug Coated Stents

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FDA to Issue New Testing Requirements for Drug Coated Stents

December 14th, 2007 amy

The FDA has announced that it plans to issue new requirements for the testing of drug coated stents. The new requirements will likely require longer testing periods and require that the stents be tested on a larger number of people. The recommended time that patients should take the anticlotting drug Plavix after getting a new stent will also be discussed in the new guidelines.

There has been great debate this past year over the dangers of drug coated stents versus the old stents used to prop open clogged arteries to relieve chest pains from heart disease. Some studies have shown that the use of drug coated stents can increase the likelihood of blood clots developing months down the road. Many doctors have reverted back to using the non-coated stents as a precaution.

The new requirements will likely be issued in the next few weeks. Drug coated stents already in the process of getting the FDA’s approval, such as the new Medtronic and Abbot made stents, aren’t expected to have to go through any additional testing.

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