Abbott's XIENCE PRIME(TM) Receives CE Mark for Treatment of Most Advanced Form of Arterial Disease in the Lower Leg

BRUSSELS, January 20, 2011 /PRNewswire/ --

- Positive Results of DESTINY Trial Supported CE Mark for XIENCE PRIME for the Treatment of Critical Limb Ischemia or Severe Claudication (Pain) of the Lower Leg

- Additional Product Launches Demonstrate Company's Commitment to Advancing Endovascular Therapy

Abbott announced today that it has received CE Mark for its XIENCE PRIME(TM) Everolimus Eluting Coronary Stent System for the treatment of critical limb ischemia (CLI) or severe claudication (pain) of the lower leg. CLI is the most advanced form of peripheral artery disease (PAD) that can ultimately lead to limb amputation. With this expanded indication, XIENCE PRIME can be marketed to treat CLI or severe claudication of the lower leg in European Union countries and others that recognize CE Mark.

"Abbott's XIENCE PRIME drug eluting stent is used by physicians throughout Europe as a key option for treating coronary artery disease, and Abbott is pleased to bring the excellent attributes of XIENCE PRIME to European patients suffering from advanced artery disease of the lower leg," said Robert Hance, senior vice president, vascular, Abbott. "Treating a diseased vessel in the lower leg with an everolimus eluting stent has generated compelling clinical data compared to treatment with a bare metal stent, and we are confident that XIENCE PRIME will become an important option for European physicians treating this critical disease."

The CE Mark for XIENCE PRIME to treat CLI or severe claudication of the lower leg is supported by the data generated on the company's XIENCE V(R) drug eluting stent from the DESTINY trial. A 140-patient, investigator-sponsored, randomized, controlled, multicenter trial, DESTINY compared the XIENCE V drug eluting stent to Abbott's bare metal stent, the MULTI-LINK VISION(R), in patients with CLI of the lower leg. Patients with lesion lengths less than 40 mm were included in this trial.

The 12-month results from DESTINY demonstrated that XIENCE V had significantly better patency (absence of vessel blockage) compared to the MULTI-LINK VISION bare metal stent at 12 months (85.2 percent XIENCE V versus 54.4 percent MULTI-LINK VISION; p=0.0001). This difference was especially pronounced between six and 12 months, where the difference in patency rate significantly diverged, as the rate for the bare metal stent fell to nearly 50 percent while the rate for XIENCE V remained above 85 percent. These results demonstrated that there is a significant benefit from an everolimus eluting stent versus a bare metal stent. The data from DESTINY were presented this week at the Leipzig Interventional Course (LINC) 2011, a medical congress held in Germany for physicians treating endovascular diseases.

"The DESTINY trial demonstrates that everolimus eluting stents result in significantly better patency at 12 months compared to bare metal stents for patients with critical limb ischemia of the lower leg, and the use of everolimus eluting stents can potentially provide significantly better outcomes for these patients," said Marc Bosiers, M.D., Head of the Department of Vascular Surgery at St. Blasius Hospital in Dendermonde, Belgium, and principal investigator of the DESTINY trial. "A drug eluting stent such as XIENCE PRIME provides European physicians with another treatment option for patients with short lesions in the lower leg."

In addition to the new indication in Europe for XIENCE PRIME, Abbott has recently launched a number of key products that provide a range of options for the treatment of endovascular diseases. The Hi-Torque(R) Winn family of guide wires is indicated to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). PTCA refers to angioplasty performed in the coronary arteries, while PTA refers to angioplasty performed in other arteries. These guide wires are available in the U.S. and Europe. In addition, the Armada 14 PTA catheter, which is available in Europe, has received 510(k) clearance in the U.S., and is indicated to dilate the arteries in the legs and kidneys.

About XIENCE PRIME and XIENCE V

XIENCE PRIME is commercially available in CE Mark countries. XIENCE PRIME offers a novel stent design and a delivery system designed for greater flexibility and enhanced deliverability. XIENCE PRIME is available in a broad size matrix, including XIENCE PRIME SV for small vessels and XIENCE PRIME LL for long lesions.

XIENCE PRIME currently is an investigational device in the U.S. and not available for sale. The expanded indication for the treatment of CLI or severe claudication (pain) of the lower leg applies to XIENCE PRIME exclusively in countries where the product bears a CE Mark.

Abbott's market-leading XIENCE V drug eluting stent is marketed in the U.S., Europe, Japan and other international markets.

Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.

Additional information about XIENCE PRIME, including important safety information, is available online at http://www.abbottvascular.com.

About Abbott Vascular

Abbott Vascular is a global leader in cardiac and vascular care with market-leading products and an industry-leading pipeline. Abbott Vascular offers a comprehensive cardiac and vascular devices portfolio, including products for coronary artery disease, vessel closure, endovascular disease, and structural heart disease.

About Abbott

Abbott (NYSE: ABT) 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 nearly 90,000 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.