Physio-Control Receives FDA 510(K) Clearance For LIFEPAK(R) 20e Defibrillator/Monitor
Physio-Control, Inc., a wholly owned subsidiary of Medtronic, Inc., (NYSE: MDT) announced today that it has received clearance by the U.S. Food and Drug Administration (FDA) to market the LIFEPAK 20e defibrillator/monitor within the United States.
The 20e is an enhancement of the LIFEPAK 20 defibrillator/monitor, which has become the standard of care in many hospitals worldwide since its introduction in 2002. It offers all the capabilities of the LIFEPAK 20 device, along with a more powerful Lithium-ion battery that doubles ECG monitoring time and the run time of other parameters such as noninvasive pacing and pulse oximetry, a noninvasive way to monitor the oxygenation of a patient’s hemoglobin. Additionally, a new on-screen “fuel gauge” displays the real-time status of available battery capacity so clinicians can monitor remaining use time.
The 20e also was developed to be easily transported, helping hospitals meet the Joint Commission for Accreditation of Healthcare Organizations (JCAHO) standard for having resuscitation services readily available in all facility areas.
“We are very pleased to have received 510(k) clearance from the FDA on the LIFEPAK 20e defibrillator/monitor. Physio-Control has a long history of providing products for the hospital marketplace and the 20e will fit well into the line of reliable, quality products customers have come to expect from us,” said Brian Webster, president of Physio-Control. “It is an exciting time for our company as we continue to provide our customers with new generations of LIFEPAK products.”
Physio-Control is currently under a consent decree with the FDA, which restricts the amount of products that can be delivered to customers until certain improvements in the company’s quality system have been completed. However, the company is permitted to manufacture and ship a limited selection of product under certain conditions to meet the critical needs of emergency response customers. Hospital staff should call their local Physio-Control representative to learn more about the specific conditions under which Physio-Control can deliver LIFEPAK 20 and LIFEPAK 20e products to U.S. hospital customers.
Physio-Control, a division of Medtronic, is located in Redmond, Wash. Physio-Control pioneered defibrillation technology more than 50 years ago. With nearly 700,000 LIFEPAK(R) defibrillators distributed worldwide, the company is the world’s leading provider of external defibrillators for the treatment of sudden cardiac arrest. To find out more about Physio-Control, go to www.physio-control.com or call 1-800-442-1142.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 25, 2008. Actual results may differ materially from anticipated results.