FDA Grants LUCAS 2 Chest Compression System 510(k) Clearance in the U.S.

Physio-Control Inc., a wholly-owned subsidiary of Medtronic, Inc. has announced that the LUCAS 2, the next-generation LUCAS Chest Compression System, has been granted 510(k) market clearance by the U.S. Food and Drug Administration (FDA). Developed and manufactured by Jolife AB and distributed exclusively in the United States by Physio-Control, the LUCAS 2 is an automated, battery-powered device that is designed to give consistent, uninterrupted compressions to victims in cardiac arrest.

Since performing manual chest compressions according to the American Heart Association guidelines is both difficult and physically demanding, Jolife created the LUCAS Chest Compression System to assist. LUCAS is designed to deliver uninterrupted compressions at a consistent rate and depth (100 compressions per minute, depth 1.5 to 2 inches) to facilitate the return of spontaneous circulation in cardiac arrest patients. By ensuring consistent blood flow, LUCAS helps emergency medical responders deliver a more viable candidate for recovery to the Emergency Department. Furthermore, LUCAS can assist in improving the operations of an emergency response system or hospital by helping to reduce the chaos on the scene and free up staff for other emergencies.

LUCAS 2 builds upon the well-proven LUCAS™ 1 technology, but differs from its predecessor in that it is an electric rather than a pneumatic device. LUCAS 2 can be powered either by battery alone or using a wall or car electricity outlet. The battery is the latest in rechargeable, Lithium Ion Polymer technology and operates for up to 45 minutes (typical) on a single battery. LUCAS 2 is equipped with Smart Restart functionality. When a battery needs to be replaced, LUCAS 2 does not have to be powered down, only put into the pause mode, and when the new battery is inserted, the start position will stay the same within 60 seconds from the pause. Operation can be quickly resumed, saving time for medical personnel. LUCAS 2 offers other new features such as alerts and pauses to aid ventilation during compressions with an unsecured airway (e.g. bag-valve-mask) and quieter operation.

“With the LUCAS 2 we now offer a solution to customers that prefer a battery-powered device, and the LUCAS 1 for those who prefer the pneumatic solution,” said Erik von Schenck, CEO of Jolife AB. “The rechargeable battery requires a minimum of maintenance, and makes the device the most compact, lightweight and portable mechanical chest compression device on the market.”

LUCAS 2 weighs only 17.2 lb (7.8kg) and fits into a compact backpack measuring just 25.6h x 13w x 19.8d inches (65h x 33w x 25d centimeters).

“We are proud that our strong partnership with Jolife has enabled us to bring another high-quality, innovative, life-saving product to the emergency care market,” said Brian Webster, president of Physio-Control. “Customers have been asking us for a battery-powered LUCAS device for a couple of years and with LUCAS 2 we are able to deliver.”

Within the past month, LUCAS 2 has also received a CE (Conformité Européenne) Mark in Europe and marketing approval from Health Canada. Physio-Control plans to begin shipping to the U.S. markets in the fall.

http://www.physio-control.com