Abbott announced on 2 November 2009 that both the Xience Prime and Xience V everolimus-eluting coronary stent system have received additional new CE markings covering the treatment of patients with diabetes.
In addition to diabetes, the two devices also received CE mark for expanded indications to treat patients that have complex disease, including dual vessels, small vessels and jailed side branches (small side branches of less than 2mm in diameter that are covered, or “jailed,” when a larger artery is stented).
The expanded indications for Xience Prime and Xience V are based on randomised clinical trial data from the SPIRIT family of trials that support the safety and performance of the stents in these patient subgroups. Xience Prime is also indicated for use in long vessels and is available in stent lengths of 33mm and 38mm. Both Xience Prime and Xience V leverage the excellent 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 Express2 paclitaxel-eluting coronary stent system were presented at the Transcatheter Cardiovascular Therapeutics annual meeting in September 2009. With 3,690 patients, the SPIRIT IV trial is one of the largest head-to-head randomised clinical trials between two drug-eluting stents and includes more than 1,100 patients with diabetes.
Xience Prime and Xience V are based upon the well-tested design utilised in the Multi-Link Vision family of stents, which is the most widely used stent platform in the world – more than 2 million of Abbott’s cobalt chromium stents have been implanted worldwide.
Xience Prime received CE mark in June 2009, and Xience V received CE mark in 2006. Xience Prime is an investigational device in the United States and is not available for sale in the United States or outside of jurisdictions in which the product has been CE marked. These additional indications apply to Xience V exclusively in countries where the product bears a CE mark.