XIENCE PRIME, XIENCE V Receive Indications in Europe to Treat Diabetes Patients


November 3, 2009
Abbott's XIENCE Prime DES

November 3, 2009 – Abbott yesterday said both the 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.

Receiving these new indications among the European Union Member States validates the use of XIENCE PRIME and XIENCE V to treat patients with diabetes. Coronary artery disease is one of the most common cardiovascular complications of diabetes and is the No. 1 cause of death among European adults with diabetes (1).

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 and jailed side branches (small side branches of less than 2 mm 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 randomized clinical trial data from the SPIRIT family of trials that support the safety and performance of the stents in these patient subgroups. XIENCE PRIME also is indicated for use in long vessels and is available in stent lengths of 33 mm and 38 mm. 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 (TCT) annual meeting in September 2009. With 3,690 patients, the SPIRIT IV trial is one of the largest head-to-head randomized 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 utilized 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.

For more information: www.xienceprime.com, www.xiencev.com or www.abbottvascular.com

(1) Ryden L, Standl E, Bartnik M, et al. “Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary: The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD).” European Heart Journal 2007;28(1):88-136