Abbott gets FDA OK to market StarClose vascular closure system

By Angela McDaniels

Seattle, Dec. 22 - Abbott Laboratories said it has received approval from the Food and Drug Administration to market its StarClose Vascular Closure System, a new vessel closure device after catheterization

"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," said Jim Hermiller of St. Vincent's Hospital in Indianapolis in a company news release.

"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."

Hermiller was an investigator in the Clip Closure in Percutaneous Procedures study, in which the median time to cessation of bleeding was 16.8 seconds for the 136 StarClose patients versus 15 minutes for the 72 patients who underwent manual compression, the company said. No infections or major vascular complications were observed in either group.

Preliminary data from the study indicated that patients whose vessels were closed with StarClose were able to get up and walk roughly two hours earlier and leave the hospital two hours sooner than those who underwent vessel closure with standard manual compression.

StarClose introduces a tiny, flexible clip on to 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 clip is made of nitinol, a nickel-titanium composite that retains its shape once released from the StarClose device.

The StarClose device launched in Europe in 2004, where it has been used successfully in over 55,000 procedures to date, the company said.

Abbott is a health care company based in Abbott Park, Ill., that develops pharmaceuticals and medical products.

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