Heart Stent Fails Test and Pulled From Market

Shannon Weidemann

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A heart stent that is used in Europe, Asia, and Latin America has failed testing in the United States and will be pulled from the market. The CoStar drug coated stent did not work as well as another already in use in the United States. The maker of the stent, Conor Medsystems will not seek FDA approval for the defective medical device.

The clinical trial showed that, after eight months, CoStar was inferior to Taxus in reducing major adverse cardiac events. While rates of heart attack and death were similar between the two stents, J&J spokeswoman Susan Odenthal explained, CoStar had higher rates of target vessel revascularization, or when symptoms recur somewhere in the treated blood vessel.

Conor said the dose of the drug used to coat the stent, the cancer drug paclitaxel, was not effective. Taxus also uses paclitaxel as a stent coating. The CoStar differs from other drug-coated stents in that it uses tiny reservoirs built into the stent to release the drug.

The company is owned by Johnson and Johnson. They plan to rework the stent using a different drug as the coating on the stent.