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Abbott Vascular Devices Unveils the
StarClose Vascular Closure System

Innovative Circumferential Clip-Based Device Provides
Secure Extravascular Closure with Simple, Quick Deployment

Paris, May 25, 2004 — Abbott Vascular Devices, a division of Abbott Laboratories, today announced the unveiling of the StarClose Vascular Closure System at the 2004 Paris Course on Revascularization (PCR) held this week in Paris, France. This introduction marks the world's first circumferential clip-based vascular closure device — ushering in a new era in vascular access closure devices. StarClose features an innovative Nitinol™ clip that is designed to promote the primary healing process to achieve a secure close of femoral artery access sites following diagnostic or interventional vascular procedures. This unique clip provides 360° tissue apposition for rapid healing and immediate hemostasis. StarClose received CE Certification in February 2004, and is available for sale in the European Economic Communities.

"As a pioneer in vessel closure technology, we are very proud of bringing to market the world's first circumferential clip vascular closure system," said Robert B. Hance, president, Abbott Vascular Devices. "The introduction of StarClose solidifies Abbott Vascular Devices as an innovative leader in vessel closure. StarClose joins a product line which includes the Perclose® suture-mediated closure family and Chito-Seal™ topical hemostasis, giving physicians a patient-centric approach when addressing a broad spectrum of clinical needs."

The device requires only four clicks to achieve a secure, "extravascular" close, which means that nothing is left inside the artery itself — the clip closes the closure site entirely from the outside of the vessel. Physician feedback regarding ease-of-use and the time it takes to close the vessel is positive. In addition, the intuitive design of StarClose shortens the learning curve for physicians.

"StarClose heralds in a new generation of rapid, simple arterial puncture site closure devices that are shown to be safe even in patients receiving strong blood thinners such as GPIIb/IIIa inhibitors," said Dr. Peter Ruygrok, Principal Investigator for the StarClose New Zealand study, Consultant Cardiologist at Auckland City Hospital and Clinical Associate Professor at University of Auckland, Auckland, New Zealand. "I have no doubt it will modernize the management of puncture sites following catheterization and percutaneous intervention."

An additional key feature of the StarClose system allows physicians to close the artery through the introducer sheath. This through-the-sheath (TTS) approach expedites patient management, as extra guide wire insertion and sheath exchange steps are removed from the procedure. Moreover, TTS allows the interventionalist to use the very same pathway established during the catheterization procedure to deliver the StarClose clip directly to the puncture site, thereby shortening the procedure for the interventionalist. StarClose is the first clip-based closure device designed to capture the benefits of TTS closure.

"The innovative StarClose system provides an original approach to managing vascular access sites," stated Tony Chou, M.D., general manager, Vessel Closure Technologies, Abbott Vascular Devices. "It incorporates a high degree of confidence in gaining hemostasis, a rapid means of deployment, and it gives physicians a true through-the-sheath approach. StarClose is the result of a focus on clinically beneficial technologies with ground-breaking advances to help the physician and patient to obtain successful procedural outcomes."

In March 2004, Abbott Vascular Devices launched the CLIP (Clip cLosure In Percutaneous procedures) study — a U.S.-based clinical trial of StarClose for extravascular closure in diagnostic and interventional cases. StarClose patients are randomized against manual compression. StarClose is currently an investigational device in the United States and is not available for sale.

About Vessel Closure
American Heart Association research indicates that more than 61 million Americans have cardiovascular disease and nearly 3 million cardiac catheterizations are conducted in the United States each year. During cardiac catheterization procedures, a long, thin tube (called a catheter) is threaded through an introducer sheath which is inserted into a major artery in the leg called the femoral artery. The catheter threads its way up to the heart to diagnose or treat certain problems with that organ and its blood supply. Traditionally, doctors have used various methods of applying compression to close the opening to the femoral artery, including direct pressure, sandbags or mechanical clamps. These approaches to vessel closure often result in significant patient discomfort and can require up to several hours to achieve hemostasis.

Since the launch of the first Perclose system in 1994, suture-mediated closure technology has enabled physicians to more quickly close the accessed vessel and reduce the bleeding after cardiac catheterization, allowing patients to ambulate safely and improving patient comfort. In addition, a prospective study indicated that use of this technology allows patients to go home sooner, requiring less nursing time for post-procedure monitoring, which may result in cost savings. Abbott Laboratories acquired Perclose, the market leader in suture-mediated vessel closure devices, in 1999.

Continuing this tradition of innovation, Integrated Vascular Systems developed the StarClose clip technology to provide another closure solution for interventionalists. Abbott acquired Integrated Vascular Systems in 2003. With the addition of StarClose, Abbott Vascular Devices now offers interventionalists the options of suture and clip — similar to how a vascular surgeon would approach the vessel to obtain a secure and clinically effective closure.

About StarClose
The StarClose Vascular Closure System is designed to deliver an extravascular Nitinol clip to close 6 French puncture sites in the femoral artery following diagnostic and interventional catheterization procedures. The system consists of the Clip Applier, Introducer Set and Exchange System.

About Abbott Vascular Devices
Abbott Vascular Devices, a division of Abbott Laboratories headquartered in Redwood City, California, 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 and medical products, including nutritionals, devices and diagnostics. The company employs more than 55,000 people and markets its products in more than 130 countries.

Source: Abbott

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