"Post-approval studies allow physicians to follow the safety and efficacy of new treatments in a more complex patient population than is typically studied in pre-approval clinical trials. XIENCE V USA will provide significant insight about the performance of Abbott's new drug eluting stent in a variety of patients," said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs and chief medical officer, Abbott Vascular. "Our ability to work with our physician partners to begin this post-approval study within days of FDA approval is further evidence of Abbott's commitment to help the interventional cardiology community gain additional insights about the clinical benefits of XIENCE V."
About XIENCE V
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. XIENCE V is built upon Abbott's market-leading bare metal stent, the MULTI-LINK VISION(R) Coronary Stent System. The VISION platform is designed to facilitate ease of delivery, making it easier for physicians to maneuver the stent and treat the diseased portion of the artery.
Long-term results with XIENCE V in the SPIRIT III pivotal U.S. clinical
trial demonstrated a 45 percent reduction in the risk of major adverse
cardiac events (MACE) compared to the TAXUS(R) paclitaxel-eluting coronary
stent system at two years. XIENCE V demonstrated a 32 percent reduction in
target vessel failure (TVF, cardiac events related to the stented vessel)
compared to TAXUS at two years. XIENCE V also demonstrated a low rate of
stent thrombosis between one and two years, defined as very late stent
thrombosis, per Academic Research
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