The FDA has approved a new medical device for removing blood clots from blocked heart arteries or bypass grafts prior to angioplasty. The device may provide an alternative treatment for patients in whom clot-busting 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. 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 takes about one minute.
Once the blood clot is removed the patient can then undergo angioplasty. Approval of the AngioJet system was based on review of clinical studies of safety and effectiveness in 731 people at 41 medical centers in the United States and Canada. The study showed that AngioJet was similar in effectiveness to urokinase. 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.