ABBOTT PARK, Ill., Nov. 5 /PRNewswire-FirstCall/ -- Abbott announced today that the U.S. Food and Drug Administration (FDA) has confirmed a Circulatory Systems Devices Advisory Panel meeting on Nov. 29, 2007, to review the company’s Premarket Approval (PMA) submission for the XIENCE(TM) V Everolimus Eluting Coronary Stent System.
Abbott filed its PMA for XIENCE V with the FDA on June 1, 2007. The company anticipates that it will launch XIENCE V in the U.S. in the first half of 2008, pending FDA approval.
The PMA for XIENCE V is the first to include data demonstrating superiority of one drug eluting stent over another in the primary endpoint of in-segment late loss in a randomized controlled head-to-head trial with a market leading product. Additionally, XIENCE V showed clinical superiority in the safety and efficacy endpoint of major adverse cardiac events (MACE). MACE is an important measure of clinical outcomes for patients, and is defined as cardiac death, heart attack (myocardial infarction or MI), or ischemia-driven target lesion revascularization (TLR associated with symptoms or documented lack of blood supply).
Abbott is providing the FDA with a subset of its two-year data from the SPIRIT II and SPIRIT III clinical trials on more than 500 total patients (nearly 400 of these patients treated with XIENCE V). These two-year data, which are being provided for the Nov. 29 FDA Panel review, are consistent with the safety results from the SPIRIT III one-year data presented last month at TCT 2007, including the safety and efficacy endpoint of MACE, as well as the rates of overall stent thrombosis.
SPIRIT III Results
In the SPIRIT III U.S. pivotal clinical trial, Abbott’s XIENCE V Everolimus Eluting Coronary Stent System met its primary endpoint and demonstrated a statistically significant 50 percent reduction in in-segment late loss at 8 months compared to the TAXUS(R) Paclitaxel-Eluting Coronary Stent System. Late loss is a measure of vessel renarrowing.
As recently reported, XIENCE V demonstrated clinical superiority to TAXUS with a significant 43 percent reduction in MACE compared to TAXUS at one year. These MACE results are consistent with the clinically superior 44 percent reduction in MACE observed for XIENCE V at nine months.
In the major secondary endpoint of Target Vessel Failure (TVF) in the SPIRIT III trial, XIENCE V demonstrated statistical non-inferiority to TAXUS at one year with an observed 23 percent reduction in TVF. TVF is a measure of re-treatment anywhere within the target vessel and includes cardiac death or heart attack. There was no evidence of a difference in either acute or late thrombosis rates between XIENCE V and TAXUS out to one year.
XIENCE V was launched in Europe and other international markets in 2006. XIENCE V is currently an investigational device in the United States and Japan.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
Abbott’s news releases and other information are available on the company’s Web site at http://www.abbott.com.
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