ABBOTT PARK, Ill, May 7, 2009 — Abbott today announced the launch of two new products for the treatment of peripheral artery disease (PAD), a condition that occurs when the vessels supplying blood to the legs, arms, stomach or kidneys become narrowed or blocked by plaque, restricting normal blood flow. The FoxCross™ PTA Catheter is a next-generation .035 balloon dilatation catheter and is now available in the United States and Europe. The HI-TORQUE Versacore™ .035 Guide Wire is a peripheral guide wire for delivery of catheters, balloons and stents and is now available in the United States.
“The FoxCross PTA Catheter and Versacore Guide Wire are the most recent examples of Abbott’s commitment to successful outcomes for physicians treating patients with peripheral artery disease,” said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. “We are pleased to add these two innovative products to our broad portfolio of minimally invasive solutions for treating cardiac and vascular disease.”
FoxCross PTA Catheter
The FoxCross PTA Catheter is used to open peripheral arteries that have become blocked with plaque. The system is available in a wide variety of diameters (3 mm to 14 mm), balloon lengths (20 mm to 120 mm), and catheter lengths (50 cm, 80 cm and 135 cm) on an over-the-wire delivery platform.
“A highly deliverable balloon dilatation catheter is key to successful patient outcomes. If the balloon does not cross the blockage smoothly and reliably, the procedure can take longer and may be prone to complications, as well as additional costs,” said Joseph A. R. Cardenas, M.D., FACC, medical director of the cardiac catheterization laboratory at the Yuma Regional Medical Center in Yuma, Ariz. “The FoxCross system offers superb crossability and impressive deflation times, making it suitable for challenging lesions.”
FoxCross is a highly deliverable balloon dilatation catheter designed to optimize the treatment of patients with peripheral artery disease during angioplasty procedures by incorporating the latest technological advancements, including:
- Proprietary JETCOAT™ coating that allows for smooth device movement and enhanced deliverability
- Streamlined tip and crossing profile for accessing and treating challenging lesions
- Dual-lumen shaft with large, crescent-shaped contrast lumen for rapid inflation/deflation
HI-TORQUE Versacore .035 Guide Wire
The HI-TORQUE Versacore peripheral guide wire is designed for routine diagnostic and device delivery in interventional procedures. Versacore features a soft, shapeable tip to provide safe access to peripheral lesions and enhanced visibility under fluoroscopy. Versacore also offers excellent torque response, enabling the device to move consistently and easily around the bends of a patient’s vascular system, even when accessing the hardest-to-reach lesions.
“The Versacore guide wire is an ideal wire because it offers excellent support, navigates difficult anatomy easily, saves time with device exchanges and simplifies the procedure. Versacore is now my workhorse wire for both diagnostic and interventional peripheral procedures,” said Prakash Krishnan, M.D., assistant professor of Medicine, Mount Sinai School of Medicine, and director of Endovascular Intervention, Mount Sinai Medical Center, in New York, N.Y.
Abbott’s Vascular Pipeline
FoxCross and Versacore are the latest innovations out of Abbott’s robust vascular pipeline. Key products in the pipeline include the Omnilink Elite™ Peripheral Stent System; a fully bioabsorbable drug eluting coronary device; and the XIENCE PRIME™ Everolimus Eluting Coronary Stent System, which builds upon the proven performance of Abbott’s market-leading XIENCE V® Everolimus Eluting Coronary Stent System. Omnilink Elite, XIENCE PRIME and the bioabsorbable drug eluting device are in development and are not available for sale.
About Peripheral Artery Disease and Angioplasty
Peripheral artery disease affects an estimated 8 million patients in the United States.* Early stages of peripheral artery disease may have especially significant health implications, as patients may experience high blood pressure, kidney dysfunction, or leg pain in conjunction with reduced ability to walk. Peripheral artery disease can be treated with medication, exercise, angioplasty, stenting or surgery.
In angioplasty procedures, a catheter with a balloon is inserted into a patient’s blood vessel and is used to open an artery that has become narrowed or blocked by plaque. In cases where stenting is appropriate, a stent is expanded against the narrowed artery wall to hold the vessel open. Stent treatment of arteries expands the lumen and improves blood flow distal to the location of the stent.
More than 1.25 million peripheral balloon angioplasty procedures are performed per year globally, including nearly 650,000 procedures annually in the United States.
About XIENCE V
Abbott’s market-leading XIENCE V drug eluting coronary stent is marketed in the United States, Europe and other international markets. XIENCE V is an investigational device in Japan and is currently under review by Japan’s Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency. It is also under review with Health Canada.
Additional information about XIENCE V, including important safety and effectiveness information, is available online at www.xiencev.com.
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.
About Abbott Vascular
Abbott Vascular, a division of Abbott, is one of the world’s leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Headquartered in Northern California, Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products.
About Abbott
Abbott 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 more than 72,000 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 www.abbott.com.