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Abbott Submits StarClose™ Vascular
Closure Device for FDA Approval Preliminary CLIP Clinical Trial Data Shows New Vascular Closure Technology Reduced Cathetereization Patient Time in Hospital Abbott Park, Illinois, April, 11, 2005 — Abbott Vascular, a division of Abbott and a market leader in vessel closure, today announced the submission of a Premarket Approval application to the U.S. Food and Drug Administration (FDA) for its StarClose™ Vascular Closure System, a next–generation vessel closure system specifically designed for the simple, quick and secure mechanical closure of femoral arteries following catheterization procedures, such as angioplasty and stent placement. "As a leader in vessel closure, Abbott is pleased to announce this important step in the development of a next–generation closure device for the U.S. market," said Robert B. Hance, president of Abbott Vascular. "In our pivotal clinical study, StarClose was shown to close femoral arteries securely and safely in a matter of seconds, reducing the amount of time patients need to remain at bedrest following a catheterization procedure." Abbott submitted its Premarket Approval application to the FDA for StarClose in February 2005, based on its completion of the CLIP (Clip cLosure In Percutaneous Procedures) clinical study, which compared the safety and effectiveness of StarClose versus manual compression to control bleeding (hemostasis) following a catheterization procedure. The StarClose Vascular Closure System is designed to quickly and securely deliver a flexible nitinol clip to mechanically appose or bind the surface of a femoral artery together following a catheterization procedure. StarClose differentiates itself from other devices by leaving nothing behind in the artery that could cause potential blockages later. StarClose received CE Certification in February 2004, and was officially launched outside of the United States in 2004. "In the CLIP study, StarClose had an outstanding safety profile," said Jim Hermiller, M.D., of The Care Group at St. Vincent's Hospital in Indianapolis, Ind., and one of two national co–principal investigators for the CLIP study. "The rate of vascular complications with StarClose was zero – equal to standard–of–care manual compression, but preliminary results showed that closing a vessel with StarClose allowed patients to get out of bed and be discharged sooner than with manual compression." The CLIP clinical trial data submitted to the FDA consisted of a study of 208 patients enrolled at 17 U.S. sites who were randomized to receive either StarClose (136 patients) or manual compression (72 patients) following catheterization. The study met its primary endpoints, with no major vascular complications occurring in either the study arm or the control (manual compression) arm. A median time to hemostasis of 16.8 seconds was achieved in the StarClose group versus 15.0 minutes in the manual compression group. Preliminary data from the CLIP study also suggested that use of StarClose allowed for earlier ambulation or mobilization (two hours earlier) and earlier discharge (two hours earlier) of patients than with standard compression. "Physicians should always be on the look–out for technology that improves patient care," stated Tony Chou, M.D., interventional cardiologist and general manager, Vessel Closure Technologies, Abbott Vascular. "Our analysis has shown that StarClose is a device that was as safe as manual compression with an extravascular approach and a design that could potentially minimize the risks associated with other methods of femoral artery closure." Catheterization The American Heart Association estimates that over 70 million Americans have some form of cardiovascular disease. Nearly 4 million catheterization procedures were performed in the United States in 2002, including angioplasty and diagnostic cardiac catheterizations, and the number of cardiac catheterizations has increased over 400 percent in the last 20 years. Catheterization describes the process of introducing a small tube or catheter into a blood vessel, often the femoral artery, in order to visualize the flow of blood to an organ or to determine if a blood vessel is diseased or damaged due to the accumulation of fatty deposits or scarring. Catheterization is the first step in interventional treatment. Interventional Treatment Interventional treatment has revolutionized the treatment of stroke and heart attack by allowing specially trained cardiologists and radiologists to potentially treat sudden and severe onset of these diseases before they happen. Interventional treatment describes the process of introducing therapeutic devices, such as balloons and stents, into the body through a catheter to treat clogged blood vessels before they have the chance to damage an organ such as the heart, and without the need for invasive open heart surgery. Vessel Closure Traditionally, doctors have used various methods of applying compression to close the opening in the femoral artery following a catheterization procedure, including direct pressure, sandbags or mechanical clamps. These historical approaches to vessel closure often result in significant patient discomfort and can require up to several hours to achieve hemostasis. With the advent of Perclose® suture–mediated closure technology in 1994, physicians were able to more quickly close the accessed vessel and reduce bleeding following cardiac catheterization, allowing patients to ambulate, or recover and walk around safely, and improving patient comfort. Abbott acquired Perclose in 1999. If StarClose is approved by the FDA, Abbott Vascular will be able to offer U.S. 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. Integrated Vascular Systems (IVS) developed StarClose clip technology and Abbott acquired IVS in 2003. About StarClose The StarClose Vascular Closure System delivers an extravascular nitinol clip to close 6 French puncture sites in the femoral artery via a through–the–sheath (TTS) approach, leaving nothing behind in the vessel that could cause blockages later. TTS expedites the closure procedure by removing extra guide wire insertion and sheath exchange steps and minimizing exposure of the sterile clip to the skin, allowing interventionalists to use the very same pathway established during the catheterization procedure to deliver the flexible nitinol clip directly to the puncture site. The StarClose Vascular Closure System consists of the Clip Applier, Introducer Set and Exchange System. 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 ease of use, safety and effectiveness in treating patients with vascular disease. Abbott Vascular is headquartered in Redwood City, Calif. For more information about Abbott Vascular, visit www.abbottvascular.com. 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 60,000 people and markets its products in more than 130 countries. Abbott |
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