ABBOTT PARK, Ill., Jan. 26 /PRNewswire-FirstCall/ -- Abbott Vascular Devices, a division of Abbott Laboratories, announced today the establishment of U.S. commercial operations of its Endovascular Technologies business unit with the launch of four products: the Xceed(TM) Nitinol(TM) Self Expanding Biliary Stent, the Xpert(TM) Self Expanding Biliary Stent, the Fox(TM) PTA Catheter and the Prostar(R) XL Suture-Mediated Closure Device. These products are being showcased at the 2004 International Symposium on Endovascular Therapy (ISET) held this week in Miami.
The Endovascular Technologies unit, which together with the Coronary Technologies unit and the Vessel Closure Technologies unit comprise Abbott's vascular devices business, will deliver an advanced portfolio of endovascular products to assist clinicians in treating noncoronary vascular disease. These products include technology that clinicians use throughout the various points of a diagnostic or interventional procedure -- from vessel dilation, to stent placement, to access site closure.
"With the establishment of commercial operations in the United States of our Endovascular Technologies unit, we are ready to provide cutting-edge products that meet the needs of U.S. clinicians and their patients," said Robert B. Hance, president, Abbott Vascular Devices. "We are pleased to offer such a well-rounded, best-in-class portfolio of stents, balloons and suture- mediated closure devices and are committed to providing the U.S. market with innovative interventional devices."
The following products have recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA):
-- The Xceed Nitinol Self Expanding Biliary Stent system is the first Abbott Vascular Devices product to utilize Freestyle(TM) Technology, a proprietary delivery system that offers its users outstanding placement accuracy with single-handed deployment. The delivery system features high flexibility and deliverability, allowing it to track smoothly through challenging anatomy. -- The Xpert Self Expanding Biliary Stent system offers the lowest profile of any self-expanding biliary stent on the market, and is the only one of its kind offering users 4 Fr sheath compatibility.
In addition, the following products, which have previously received FDA 510(k) clearance, complete the Endovascular Technologies unit's initial U.S. product offering:
-- The Fox PTA Catheter offers interventionalists a reliable solution to all of their percutaneous transluminal angioplasty (PTA) challenges (i.e., the balloon dilation of narrowed arteries). The Fox PTA Catheter is composed of an advanced dual lumen design that provides for rapid balloon inflation and deflation. Its low profile, tapered tip, and SLIC(TM) hydrophilic coating provide for excellent deliverability. The Fox PTA Catheter combines these attributes with a unique balloon material that delivers controlled compliance and rated burst pressures of up to 15 atmospheres. -- The Prostar XL Suture-Mediated Closure Device is the only arterial closure device cleared by the FDA for use in punctures up to 10 Fr and is compatible with 0.038" guidewires or smaller. The Prostar XL Suture-Mediated Closure Device delivers two sutures to the vessel wall to promote primary healing through complete tissue apposition. It features two 3-0 braided polyester sutures and four Nitinol needles.
Abbott Vascular Devices already markets the Fox PTA Catheter, Xpert Self Expanding Stent system, and the Prostar XL Suture-Mediated Closure Device internationally. Other noncoronary vascular medical device products offered internationally by the company's Endovascular Technologies unit include: WavemaX(TM) Balloon Expandable Stent, SGX(TM) Peripheral Stent Graft, Xact(TM) Carotid Stent and the Emboshield(R) Bare Wire Cerebral Protection System.
About Abbott Vascular Devices
Abbott Vascular Devices, a division of Abbott Laboratories headquartered in Redwood City, Calif., is a medical technology pioneer that combines its entrepreneurial spirit with Abbott's pharmaceutical heritage to deliver specialized treatment options that dramatically improve the care of people with vascular disease. Abbott Vascular Devices brings the best of these backgrounds together to develop unique products that meet the specialized needs of vascular disease treatment through three main business units: Vessel Closure Technologies, Coronary Technologies and Endovascular Technologies.
About Abbott Laboratories
Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals, nutritionals and medical products, including devices and diagnostics. The company employs more than 70,000 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/ .
Abbott LaboratoriesCONTACT: Media, Jonathon Hamilton, +1-847-935-8646, or cell,+1-847-772-6421, or Financial Community, Christy Wistar, +1-847-938-4475, bothof Abbott Laboratories
Web site: http://www.abbott.com/
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