Challenge Drug-Eluting Stent

This state-of-the-art product is a highly flexible modular ring stent with a resorbable composite coating eluting the anti-proliferative drug everolimus.

In developing the Challenge stent, Biosensors drew upon its cross-disciplinary capabilities in device design and engineering, polymers and pharmaceuticals to create a strong contender in a medical devices product category estimated to reach $5 billion in the U.S. alone by 2005.

Coronary stents are metal-mesh tubes which are used to support blood vessels so as to prevent narrowing (or stenosis) of the vessels following surgical angioplasty. Unfortunately, the body's natural reaction to the presence of a foreign object, namely the stent, is to proliferate new tissue around it. This restenosis, defined as re-narrowing of the vessels after surgical procedures such as PTCA or stenting, can reverse the surgical benefit of improved blood flow, and can even call for repeat surgery, which in some patients may not be practicable.

With drug-eluting stents such as Challenge, drugs coated on the stent are gradually dissolved ("eluted") into the bloodstream to prevent post-surgical restenosis. Drug-eluting stents, by supplying drugs to prevent tissue build-up, can better address the problem of restenosis than bare-metal devices.

On March 19, 2003, Biosensors was pleased to announce an agreement transferring this product line to Guidant Corporation in consideration for an initial $20 million fee and a series of milestone and licensing payments. Guidant is pursuing development of this product to compete against the Cypher stent fielded by Johnson & Johnson and Boston Scientific's Taxus paclitaxel-eluting stent.

The therapeutic benefits of drug-eluting stents include the ability to treat patients earlier in the coronary disease process, fewer drug-toxicity problems than pharmaceutical strategies allow, and more encouraging prognoses than existing treatments provide.

Biosensors is researching new stent technologies, including innovations using its proprietary expertise in polymers and coating technologies, and has developed a proprietary drug, Biolimus A-9, from the same family of compounds as everolimus, to serve as a next-generation stent-eluted pharmaceutical.