Abbott Receives FDA Approval for
StarClose™ Vascular Closure System
Flexible Clip-Closure Device Brings Faster, Safe and Secure Vessel Closure to the United States
ABBOTT PARK, Ill., Dec. 22 -- Abbott today announced it
received Food and Drug Administration (FDA) approval to market its StarClose™ Vascular
Closure System, a new vessel closure device engineered to enable faster, safe
and secure closure and earlier patient mobilization after catheterization.
StarClose introduces a tiny circumferential flexible clip onto the surface of the femoral artery, closing the artery securely in a matter of seconds following diagnostic catheterization procedures such as those used to diagnose coronary artery disease. The StarClose clip is designed for delivery "through-the-sheath" -- a feature intended to avoid contact with the skin and thus decrease the risk of infection. Physicians can quickly and easily deliver the clip to the surface of a femoral artery with a series of four clicks of the device. The clip is made of nitinol, a nickel-titanium composite that "remembers" its shape once released from the StarClose device.
"StarClose has the potential to change the current standard of vessel closure, which is manual compression -- a hands-on procedure that involves squeezing the outer surface of the upper thigh for several minutes to stop bleeding," explained Jim Hermiller, M.D., The Care Group at St. Vincent's Hospital, Indianapolis, Ind. "It is in the patient's and physician's best interest to close the femoral artery as securely, quickly and cleanly as possible to reduce complications, as well as allow patients to get up and walk around sooner." Dr. Hermiller was one of two national co-principal investigators in the CLIP (Clip CLosure In Percutaneous Procedures) Study, which Abbott completed to gain approval for StarClose.
The CLIP Study
The CLIP Study compared the safety and efficacy of StarClose versus manual compression in 208 patients who underwent diagnostic catheterization procedures. The StarClose device showed a significant advantage over manual compression in time to hemostasis (cessation of bleeding) and time to ambulation (walking around). Median time to hemostasis was 16.8 seconds for the 136 StarClose patients versus 15.0 minutes for the 72 patients who underwent manual compression. No infections or major vascular complications were observed in either group. Major vascular complications were defined as vascular injury requiring repair, new ipsilateral (same side of the body as the catheter insertion) lower extremity ischemia, transfusion, infection and nerve injury.
Preliminary data from the study indicated that patients whose vessels were closed with StarClose were able to get up and walk approximately two hours earlier and leave the hospital approximately two hours sooner than those who underwent vessel closure with standard manual compression.
"Whether it is used for first-time or repeat procedures, StarClose is designed to enable safe, effective and consistently secure closure of the femoral artery puncture site," said Tony Chou, M.D., a practicing interventional cardiologist and general manager of Abbott Vascular Vessel Closure Technologies. "When it comes to closure, the physician wants the confidence of knowing that the patient is on his or her way to healing and resuming normal activities of daily living. StarClose was designed with this in mind."
Abbott launched StarClose in Europe in 2004 where it has been used successfully in over 55,000 procedures to date.
For important safety information regarding Abbott's StarClose Vessel Closure System, please visit http://www.abbottvascular.com/starclosebrief .
About Catheterization Procedures
Catheterization procedures involve the insertion of a small plastic tube or catheter into an artery, most often the femoral artery in the leg. Diagnostic catheterization is the first step interventional physicians perform to diagnose vascular disease in patients. During diagnostic catheterization, dye is injected into a vessel and the extent of disease is visualized by x-ray. Interventional physicians use diagnostic catheterization to determine the best course of treatment for patients.
About Vessel Closure Following Catheterization Procedures
It is estimated that more than 5.2 million catheterization procedures will be performed in the U.S. in 2005 and that closure devices will be used in 32 percent of these procedures. As the number of catheterization procedures has risen, so has the need for new technology that enables secure closure of the femoral artery catheterization site, and that safely allows patients to get up and walk around sooner after treatment.
Once a catheterization procedure is completed and the catheter is withdrawn, the site of vessel entry (the puncture site) must be closed. Over the years, a variety of methods, such as direct pressure (manual compression), sandbags and mechanical clamps, have been used to close the puncture site and achieve hemostasis (cessation of bleeding). Many of these methods have proved less than satisfactory, causing patients significant discomfort and requiring up to several hours of bed-rest.
About Abbott Vascular
Abbott Vascular, a division of Abbott, is transforming the treatment of vascular disease, combining the latest medical device innovations with world-class pharmaceuticals to advance medicine and improve patient care. Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products that are recognized internationally for their safety, effectiveness and ease of use in treating patients with vascular disease. Abbott Vascular is headquartered in Redwood City, Calif. For more information on Abbott Vascular, visit http://www.abbottvascular.com .
About Abbott
Abbott (NYSE: ABT - News) 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 60,000 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 .
Source: Abbott |
