Taxus Express

On March 4, 2004, Boston Scientific announced that Taxus Express, its paclitaxel-eluting stent system for the treatment of coronary artery disease, had received FDA approval. The company indicated that it planned to launch Taxus Express in the United States immediately. Cordis Corporation’s Cypher™ stent (see Week and the newly approved Taxus stent are currently the only FDA approved drug-eluting stents available for use in the United States.

Unlike traditional or ‘bare metal’ stents, the Taxus stent is coated with a substance named paclitaxel and a unique polymer. The stent props the blocked coronary artery open while the polymer gradually releases the paclitaxel into the vessel wall to stop the growth of scar tissue which causes restenosis. The pivotal Boston Scientific sponsored Taxus IV clinical trial reported an in-segment (stented vessel segment plus 5 mm beyond each end of the stent) binary restenosis (50% or greater vessel re-occlusion) rate of 7.9% in the Taxus group compared with 26.6% in the control group (P=<0.0001). The study also reported a target lesion revascularization (TLR) rate of 3.0% in the Taxus group compared with 11.3% in the control group (P=<0.0001). TLR (or retreatment) rate is one of the most accurate indicators of the performance of drug-eluting stent technology.

In excess of five million Americans are treated for coronary artery disease each year. Most of these patients (about 80%) are treated medically, however, in excess of 1million patients will require more invasive procedures like Coronary Artery Bypass Grafting (CABG) or angioplasty. Among those patients receiving stents, 15-20% will require repeat treatment for restenosis. Industry analysts value the drug-eluting stent market in the 3-4 billion dollar per annum range with some predicting a 5 billion dollar market within the next 2 years. The actual direct cost increase associated with Taxus compared to a bare metal stent is significant. Each Taxus stent will likely cost between $2500 and $3000. This represents an increase of 200-300% over the per unit cost of a bare metal stent. It is duly noted that the significant decrease in restenosis rates and therefore revascularization procedures may ultimately reduce the cost per patient treated by a given health services organization.

The Taxus Express stent is currently in our High Impact Technology category. All clients with significant cath-lab operations should commence or continue assessment activities as soon as possible.

Technology Details
Target Disease / Indication: Coronary Artery Disease
Technology Classification: Combination Drug/Device
Body System: Cardiovascular System
Program Area: Cardiology
Regulatory Status: Approved

BioHorizon Impact Score: 84/100 – High