FDA approves Medtronic subsidiary’s new automated CPR device

Physio-Control, which is wholly owned by Medtronic Inc., won 510(k) clearance to distribute the LUCAS 2 Chest Compression System. This second version of the device is powered by batteries or an electrical outlet, while the previous version was powered by air -- often being attached to an air tank at the site of an emergency.

MINNEAPOLIS, Minnesota — A Medtronic Inc. subsidiary will this fall start to sell a new version of its automated chest-compression device in the United States after winning early clearance from the U.S. Food & Drug Administration.

Physio-Control, which is wholly owned by Medtronic, won 510(k) clearance to distribute the LUCAS 2 Chest Compression System. Paramedics, firefighters and emergency physicians use the device to automate cardiopulmonary resuscitation, or CPR.

This second version of the device is powered by batteries or an electrical outlet, while the previous version was powered by air — often being attached to an air tank at the site of an emergency. Its batteries usually last 45 minutes, according to a Medtronic release.

Physio-Control said its device will help improve CPR treatment, particularly as guidelines for the procedure evolve. The company says the quality of manual CPR degrades quickly, while using its device lets emergency responders use their hands for other emergencies. This is not a one-size-fits-all device, though, and it’s sometimes too big (or too small) for some patients.

LUCAS 2 also was recently approved for sale in Canada and Europe.

Physio-Control accounted for $343 million in Medtronic’s revenue in the 2009 fiscal year — about 2 percent of total sales.

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