The Boston Scientific Corporation (NYSE: BSX) has finally received a FDA "approvable letter" for the Taxus Liberte Stent, a drug-coated stent which is used to open clogged arteries. In other words it supports open heart arteries that use medication to fight against the process of renarrowing.
This product was for a long time at the center of a claim of patent infringement on the part of Boston Scientific, which was found liable for $431 million in damages, and that prevented it from flooding the American market.
Now the worldwide developer, manufacturer and marketer of medical devices is one step closer to getting Taxus Liberte Stent pushed through as the approvable letter means that FDA is ready to approve a product but still in need of more information and trials.
Another attempts to introduce the coated stent into the U.S. market ended in multiple concerns over the safety of the device. The latest information and studies paint a more favorable picture of the device. The most important among them is the study that enables elimination of mechanical widening of a narrowed or totally obstructed blood vessel, or angioplasty.