Abbott Submits StarClose Vascular Closure System for FDA Approval

Abbott Vascular has submitted a premarket approval application to the 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.

Abbott submitted its premarket approval application to the FDA for StarClose in February, 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 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 Marking in February 2004, and was officially launched outside of the U.S. that same year.