Abbott Vascular, a division of Abbott and a market leader in vessel closure, has submitted a pre-market approval application to the US 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.

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.

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 (haemostasis) following a catheterization procedure.

Robert B. Hance, president of Abbott Vascular said, "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."

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.

If StarClose is approved by the FDA Abbott Vascular will be able to offer US 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.