Physio-Control Receives Market Approval From Health Canada For LIFEPAK(R) 15 Monitor/Defibrillator

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Heart Disease;  Medical Devices / Diagnostics
Article Date: 23 Sep 2009 - 18:00 PDT

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Physio-Control, Inc., a wholly owned subsidiary of Medtronic, Inc., (NYSE: MDT) announced today it received approval by Health Canada to market the LIFEPAK 15 monitor/defibrillator within Canada. Official license notification was received on Sept. 1, 2009.

Physio-Control was granted CE mark in January 2009, certifying compliance with the European Union Medical Device Directive and began its U.S. market release of the LIFEPAK 15 monitor/defibrillator in March 2009.

The LIFEPAK 15 monitor/defibrillator builds on a 54-year Physio-Control heritage of providing innovative, reliable equipment to lifesaving teams around the world. With an all-new product platform, it delivers best-in-class clinical and operational innovations and raises the bar on the legendary LIFEPAK® standard for durability.

Clinically innovative, the LIFEPAK 15 provides the widest range of energy dosing up to 360 joules, and the broadest selection of monitoring options available. It continues Physio-Control's legacy of industry firsts as the first monitor/defibrillator to integrate Masimo Rainbow SET® Pulse CO-Oximetry™ technology for the noninvasive detection of carboxyhemoglobin (carbon monoxide in the blood; the leading cause of poisoning death in industrialized countries1) and methemoglobin in the blood (which may result from exposure to certain chemicals and drugs).

The design focuses on several key operational innovations which include the largest color screen on the market, with a one-touch button that flips the screen to high-contrast SunVue™ mode for easy viewing in sunlight; along with 10 times the processing speed and three times the battery life of its predecessor. Needed for the harshest rescue environments, Physio-Control developed the LIFEPAK 15 to be tougher than any other monitor/defibrillator on the market. For current LIFEPAK customers, this model reduces transition costs, with a user interface that complements the market-leading LIFEPAK 12 defibrillator/monitor. Emergency care providers are able to work with a mixed fleet of LIFEPAK monitors, and transition their equipment when budgets allow-enabling them to save on critical operational costs and minimize their overall training resources.

"Physio-Control has been developing and refining monitoring and defibrillation technology for more than 50 years. With the latest approval for distribution by Health Canada the LIFEPAK 15 continues to build momentum in the marketplace and is setting the new standard for emergency care products," said Brian Webster, president of Physio-Control. "The '15' has already been put into use by multiple leading EMS systems around the world."

Masimo Founder and CEO, Joe E. Kiani, stated, "The LIFEPAK 15 monitor with Masimo Rainbow SET Pulse CO-Oximetry technology represents a significant advancement for emergency first responders who provide lifesaving care and treatment to combat a range of silent killers. The combination of a defibrillator with noninvasive carboxyhemoglobin (SpCO) and methemoglobin (SpMet) monitoring capabilities means that more cases of potentially life-threatening conditions may be detected and treated earlier to improve patient safety, outcomes and recoveries."

About Physio-Control

Physio-Control, a wholly-owned subsidiary of Medtronic, is located in Redmond, Wash. Physio-Control pioneered defibrillation technology more than 54 years ago. With nearly 800,000 LIFEPAK® defibrillators distributed worldwide, the company is the world's leading provider of external defibrillation and monitoring technology for the treatment of sudden cardiac arrest and other cardio-respiratory emergencies. To find out more about Physio-Control, go to http://www.physio-control.com or call 1-800-442-1142.

Source
Medtronic