Abbott Labs Wins Approval for Drug Eluting Stent

Abbott Labs (NYSE: ABT) was given SFDA approval for its Xience V drug eluting stent system as a treatment for coronary artery disease (CAD), the leading cause of death in China. The approval was based on two worldwide clinical trials that enrolled 1302 patients, including 60 patients from two sites in China. Abbott says it plans to launch the device in Q4. It first became available in western countries in 2006.

In the clinical trial, Xience V was compared to the Taxus Paclitaxel-Eluting Coronary Stent System, a Boston Scientific (NYSE: BSX) product. Xience V reduced the incidence of major adverse cardiac events by 45% (7.1% for Xience against 12.3% for the Taxus stent) over the first two years. Abbott also claims improved ease of implantation for its product. The Abbott stent demonstrated a low rate of repeat procedure and stent thrombosis in the trial’s diverse patient population.

Xience V releases everolimus to prevent re-blockage of the artery after a stent procedure. Everolimus, developed by Novartis Pharma (NYSE: NVS), is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott for use on its drug eluting stents. Xience V is built upon Abbott's market-leading bare metal stent, the Multi-Link Vision Coronary Stent System. The Vision platform is designed to facilitate ease of delivery, making it easier for physicians to maneuver the stent.

According to the China Chronic Heart Disease 2006 Annual Report, coronary artery disease causes nearly 50% of all deaths in China. Approximately 150,000 patients undergo a stent procedure for the treatment of CAD each year, a number that is growing by more than 20% annually.

Disclosure: none.