To: BobKuz who wrote (61454 ) 3/13/1999 7:23:00 PM From: RRICH4 Respond to of 119973
Possis Medical's AngioJet Wins FDA Approval for New Use Possis Medical's AngioJet Wins FDA Approval for New Use Washington, March 12 (Bloomberg) -- Possis Medical Inc. said its already-approved AngioJet device won wider government clearance for use inside the heart. The company said it won U.S. Food and Drug Administration approval of the artery-clearing device for use in patients who are undergoing a heart attack, who have severe chest pains known as angina, or who can't take drugs that are generally used to dissolve a blood clot. ''It's a very broad approval,'' said Russel Carlson, chief financial officer of Possis. ''It's everything that we asked for, and it allows us to start marketing now.'' News of the approval came after the close of trading on U.S. markets. Shares in the money losing device-maker closed unchanged at 12 3/8. Other Uses The company is also developing the AngioJet, first approved in 1996 for use in a small set of patients, for a host of other indications in addition to cleaning clots from heart vessels. ''It even has applications such as liposuction,'' chief executive officer Robert Dutcher said during an interview with the Bloomberg Forum earlier this year. ''Our goal is to get it out there in-cardio, and then we'll expand.'' The device is already approved for the removal of clots from the permanently implanted vein grafts used to hook dialysis patients to the machines that clean their blood. AngioJet consists of a small hollow wire that runs the length of a flexible catheter. The wire ends in a tight U-turn and is tipped with a shower-head pointing back down the catheter. The catheter is threaded until it reaches a clot, then water is pumped at high pressure through the tube to the end of the catheter, and shot out the shower head at half the speed of sound. Clots are suctioned into the catheter by the vacuum created by the intense water pressure and destroyed by the speed of the water as they are shot back away from the patient's body. NYSE/AMEX delayed 20 min. NASDAQ delayed 15 min.