LOUISVILLE, Colo., Feb. 4 /PRNewswire/ -- Medivance, Inc., a leader in the emerging field of therapeutic temperature management, announced today that three new studies of hypothermia therapy in stroke patients will be presented at the American Heart Association's 29th International Stroke Conference, February 5-7 in San Diego. The studies were conducted with the Medivance Arctic Sun 2000 Temperature Management System, the first non-invasive patient cooling system that precisely controls, monitors, and maintains core body temperature to induce mild hypothermia. Mild hypothermia could potentially improve the recovery and quality of life for patients who have suffered stroke, cardiac arrest, and other traumatic disorders. Medivance has received 510(k) clearance from the FDA to use the Arctic Sun to control temperature between 33 degrees and 37 degrees Celsius (approximately 91.4 degrees and 98.6 degrees Fahrenheit).
In the first of the three studies, Gene Sung, MD, director, Neurocritical Care and Stroke Program at the University of Southern California, will be reporting on the CHILI Study: Controlled Hypothermia in Large Infarction. This study, currently in progress, is designed to determine whether mild to moderate hypothermia using an external cooling method is both feasible and efficacious. Dr. Sung will present the CHILI Study at the Ongoing Clinical Trials Poster Session on Thursday, February 5th, from 5:30-7:30 p.m. in Hall E.
On the following day, Stephan Mayer, MD, director, Neurological Intensive Care Unit at Columbia Presbyterian Medical Center in New York, will present results of a clinical study comparing the use of the Arctic Sun system to conventional temperature management methods to control fever in critically ill stroke patients. "Fever exacerbates ischemic neuronal injury and has been associated with poor outcomes after ischemic and hemorrhagic stroke," said Dr. Mayer. "Our study found that the Arctic Sun is superior to conventional methods for controlling fever in febrile, critically-ill stroke patients." Dr. Mayer's findings will be delivered during the In-Hospital Poster Session on Friday, February 6th, from 5:30-7:30 p.m. in Hall E.
Also that evening, Richard Zweifler, MD, director, USA Stroke Center at the University of South Alabama, will present the results of a third study using magnesium sulfate to increase the rate of cooling with the Arctic Sun system. Dr. Zweifler said, "Therapeutic hypothermia has been proven effective following cardiac arrest and shows promise as a treatment for acute stroke. Our study found that the infusion of magnesium sulfate during treatment with the Arctic Sun was safe and increased cooling rates as well as patient comfort." Dr. Zweifler's study was conducted in 22 healthy volunteers and will be presented at the Acute Management Poster Session on Friday, February 6th, from 5:30-7:30 p.m. in Hall E.
Arctic Sun 2000 Features
The Arctic Sun system consists of the Arctic Sun Control Module and patented Arctic Sun Energy Transfer Pads(TM). The system's simple, safe and easy-to-use design allows nursing staff to initiate hypothermia therapy soon after a patient is presented for care. The system can accurately and rapidly monitor and control a patient's temperature in the range of 33 degrees to 37 degrees Celsius (91.4 degrees and 98.6 degrees Fahrenheit). The patient's current temperature -- measured by standard temperature probes -- and a preset target temperature provide feedback that adjusts the temperature of circulating water from the control module through the pads based on a proprietary thermoregulatory algorithm. This precise control and the system's efficiency enable quick and easy induction of mild hypothermia.
The Arctic Sun Energy Transfer Pads are coated with a hydrogel material that gently adheres to the patient's skin, resulting in excellent pad-to-skin contact. A set of pads covers less than 40 percent of body surface area during cooling procedures. High velocity, temperature-controlled water flows through the pads to modify patient temperature. The result is a thermoregulatory system that achieves and maintains a preset target temperature and is more efficient and precise than traditional methods of surface temperature management. The pads can remain in place on the same patient for up to 72 hours, and can be removed or replaced without pulling on hair or skin. The Arctic Sun Energy Transfer Pads do not contain latex or any metal components that would interfere with magnetic resonance imaging.
Product Availability
The Arctic Sun 2000 is currently available for sale in the United States and will be available in Europe later this year. Medivance will be exhibiting the Arctic Sun 2000 during the International Stroke Conference at booth #215.
Mild Hypothermia Heating Up as a Mainstream Treatment Option
According to the American Heart Association (AHA), 700,000 strokes and 250,000 sudden cardiac arrests occurred in the United States in 2002 resulting in significant neurological deficits in survivors. A growing body of research demonstrates the important role that cooling can have on neurological outcomes and an August 6, 2003 New York Times article, entitled "Hope Rises for Patient Cooling Therapy," has continued to raise awareness on a national level.
Mild hypothermia therapy received much attention on the heels of a major endorsement by the AHA and the Advanced Life Support Task Force of the International Liaison Committee on Resuscitation in July 2003. The committee noted, "There seems to be good evidence to recommend the use of induced mild hypothermia in comatose survivors of out-of-hospital cardiac arrest caused by VF (ventricular fibrillation)."
About Medivance
Medivance, Inc. is a medical products company based in Louisville, Colorado that develops and manufactures non-invasive, proprietary therapeutic temperature management solutions. It provides clinicians with safe, easy, and precise methods to control and regulate body temperature. Established in hospitals across North America, Medivance's solutions have applications in complex surgical procedures and intensive care settings, as well as potentially in the care of patients who have suffered cardiac arrest, heart attacks, or strokes.
Founded in 1998, Medivance has raised more than $35 million from principal investors that include Cross Atlantic Partners, Camden Partners, Credit Suisse First Boston, Kimberly-Clark Ventures, Partisan Management Group, and Skyline Ventures. This figure includes proceeds from a June 2003 agreement with Kimberly-Clark Health Care, which acquired a portion of Medivance's business. For more information, visit http://www.medivance.com/ .
(C) 2004 Medivance, Inc. All rights reserved. Medivance, Arctic Sun, and Arctic Sun Energy Transfer Pads are trademarks of Medivance, Inc. Federal Law (USA) restricts this device to the sale by or on the order of a physician.
Medivance, Inc.CONTACT: Edna Kaplan, office +1-781-639-1910, cell +1-617-974-8659,Kaplan@kogspr.com, or Phyllis Laorenza Linnehan, office +1-781-275-7226,phyllis@kogspr.com, both for Medivance, Inc.
Web site: http://www.medivance.com/