Abbott has announced that Xience Prime everolimus eluting coronary stent system and the Xience V everolimus eluting coronary stent system have received additional new CE Markings covering the treatment of patients with diabetes.
In addition to diabetes, Xience Prime and Xience V also received CE Mark for expanded indications to treat patients that have complex disease, including dual vessels, small vessels. The expanded indications for Xience Prime and Xience V are based on randomized clinical trial data from the SPIRIT family of trials that support the safety and performance of the stents in these patient subgroups.
Both Xience Prime and Xience V leverage the outcomes from the extensive body of clinical evidence from the SPIRIT family of clinical trials. Most recently, data from the company’s SPIRIT IV trial comparing Xience V to the taxus express paclitaxel-eluting coronary stent system were presented at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in September 2009.
Charles Simonton, divisional vice president of medical affairs and chief medical officer of Abbott Vascular, said: “This expanded indication further confirms Xience Prime and Xience V as important options for physicians who are treating patients with diabetes. The deliverability of both devices provides physicians with confidence to easily reach the lesion site.”