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T99-13                        Sharon Snider:       301-827-6242
March 15, 1999                
                              Consumer Inquiries:  888-INFO-FDA

FDA APPROVES NEW DEVICE TO REMOVE BLOOD CLOTS FROM CORONARY ARTERIES

The Food and Drug Administration has approved a new medical device for removing blood clots from blocked heart arteries or bypass grafts prior to angioplasty.

The device will provide an alternative treatment to so- called clot-busting drugs, and will be particularly useful for patients in whom these drugs cannot be used.

The product, the AngioJet System, received expedited review by the FDA. It was approved less than six months after receipt of a marketing application from the manufacturer, Possis Medical, of Minneapolis, Minn.

The device is a coronary catheter system that shoots a jet of saline solution back into the tip of the catheter to suck out blood clots. Treatment with this device takes about one minute. Once the blood clot is removed the patient can then undergo angioplasty, a procedure intended to remove the arterial blockage.

Blockages in heart arteries are sometimes complicated by blood clots, resulting in heart attack or death. Currently these clots are treated with clot-busting drugs. However, for various medical reasons, many people cannot take such drugs. The new device will provide an alternative method to treat these patients.

Approval of the AngioJet system was based on review of clinical studies of safety and effectiveness conducted by the manufacturer.

The company studied 731 people at 41 medical centers in the United States and Canada who had come to the hospital with symptoms of a heart artery blockage. In one study, 180 were treated with AngioJet, and 169 were treated with urokinase, a clot-busting drug. The study showed that AngioJet was similar in effectiveness to urokinase.

In another study, 105 patients who could not be treated with clot-busting drugs were treated with AngioJet. The study showed the device to be similarly effective in these patients. Another study showed that AngioJet could be effectively used along with other treatments to remove blood clots during a heart attack.

The AngioJet System was previously approved to treat blood clots in dialysis grafts.

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