Abbott Gets Chinese Regulatory Approval For Xience V Stent - Update

(RTTNews) - Monday, before the bell, healthcare company Abbott (ABT) said it has received approval from Chinese State Food and Drug Administration, or SFDA, for its Xience V everolimus eluting coronary stent system for the treatment of coronary artery disease. The company plans to launch the stent in China during the fourth quarter.

Approximately 150,000 patients undergo a stent procedure each year for the treatment of coronary artery disease, and the number of procedures is growing by more than 20% each year in China, Abbott said.

Xience V is used to treat coronary artery disease by propping open a narrowed or blocked artery and releasing the drug, everolimus, in a controlled manner to prevent the artery from becoming blocked again following a stent procedure. Once in place, the Xience V stent will remain as a permanent implant in the coronary artery.

The company said that earlier results of Xience V demonstrated a 45% reduction in the risk of major adverse cardiac events compared to Boston Scientific's Taxus Paclitaxel-Eluting Coronary Stent System, two years after the stent implantation.

"Clinical trial results show that XIENCE V has a strong safety and efficacy profile, with impressively low rates of major adverse cardiac events and target vessel failure. Based on the strength of the data supporting it, XIENCE V is a welcome addition to the heart disease treatment options available to physicians in China," said Yong Huo, president-elect, Chinese Society of Cardiology.

Abbott's Xience V drug eluting stent is marketed in the United States, Europe and other international markets. Xience V is an investigational device in Japan, the largest drug eluting stent market in the Asia-Pacific region, and approval for the device is anticipated at the end of this year.

ABT is currently trading at $46.83, up on NYSE.

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