FDA Approves Heart Stent Study
The FDA granted Conor Medsystems Inc. full approval to enroll up to 1,700 patients in its heart stent clinical trial.
The study will test Conor’s CoStar heart stent coated with the cancer drug paclitaxel at 85 clinical sites to see if it reduces incidents of major adverse cardiac events such as heart attacks, compared with Boston Scientific Corp.’s Taxus Express2 stent, which is also coated with paclitaxel.
Stents are tiny wire mesh tubes that are expanded inside plaque-congested heart arteries with a balloon to act as scaffolding to keep the blood vessel open. Best-selling stents are coated with drugs to help prevent the artery from reclogging by keeping tissue from growing through the mesh. Conor claims the CoStar is different from other drug-coated stents, in that it uses tiny reservoirs built into the stent to release the drug.
However, Conor and Canadian specialty drug maker Angiotech Pharmaceuticals Inc. are in legal battles in several countries over Angiotech’s patents for using paclitaxel to coat stents. Angiotech licenses and supplies the drug to Boston Scientific to coat the Taxus Express2 stent.