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ALSIUS Receives 510k Market Clearance for the ICY and Fortius Catheters/CoolGard 3000 Thermal Regulation System.

Business Editors/Health/Medical Writers

IRVINE, Calif.--(BUSINESS WIRE)--Nov. 3, 2003

ALSIUS(R) Corp., a pioneer in intravascular temperature management therapies, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market its ICY(TM) and Fortius(TM) Catheters in combination with the CoolGard 3000(R) Thermal Regulation System. The products are indicated for use in Cardiac Surgery, to achieve and/or maintain normothermia during surgery and recovery/intensive care, and in Neurosurgery, to induce, maintain and reverse mild hypothermia in surgery and recovery/intensive care.

Clinical studies have shown the importance of tight control of patient temperature in the operating room during both cardiac and neurosurgery. In patients undergoing cardiac surgery, the effects of anesthesia and cool temperatures in the operating room often create an undesired drop in patient temperature. Clinicians struggle to keep patients warm to prevent shivering upon completion of the operation and into the recovery room. Shivering places additional strain on already damaged heart muscle and has shown to have a negative impact on a patient's length of stay in the hospital.

In neurosurgery, clinicians routinely cool patients 3-4(degrees) C below normal temperatures during neurosurgical repair of aneurysms to protect the brain tissue during the operation. The cooling is followed by actively rewarming the patient back to normal temperature at the end of the procedure to prevent post-operative complications. Current techniques involve a combination of surface methods and infusion of fluid to try to affect changes in body temperature.

ALSIUS' technology features the ICY(TM) and Fortius(TM) heat-exchange catheters and CoolGard 3000(R) Thermal Regulation System. The catheters provide a combination of central venous access and effective regulation of core body temperature. The catheter features heat exchange balloons in which cool or warm sterile saline continuously flows in a "closed loop" fashion. The CoolGard 3000(R) system remotely senses changes in patient temperature and adjusts the temperature of the sterile saline flowing within the balloons as needed. The result is efficient regulation of patient temperature by controlling temperature from the "inside-out."

"We are pleased to add the ICY and Fortius catheters to our product offering in the United States," said Bill Worthen, president and CEO of ALSIUS. "The expanded CoolGard 3000 indications for use in cardiac and neurosurgery represent another major milestone for our company and strengthens our leadership position in the area of temperature regulation technology."

About ALSIUS Corp.

ALSIUS (the Latin translation for "cool") develops advanced intravascular temperature management therapies for critically ill patients in the intensive care and surgical setting. The Cool Line Catheter(TM), Icy Catheter(TM), Fortius Catheter(TM) and CoolGard 3000(R) System are also CE-marked for commercial sale in Europe. ALSIUS is a privately held company, with headquarters in Irvine, and a European Service Center in Netherlands. For additional information, visit
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Publication:Business Wire
Date:Nov 3, 2003
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