IntriCon Receives FDA 510(k) Marketing Clearance

IntriCon Corporation, a designer, developer, manufacturer and distributor of miniature and micro-miniature body-worn devices, has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA), for the Centauri Ambulatory Patient ECG, its first-generation wireless cardiac diagnostic monitoring (CDM) device. The Centauri combines event recording with wireless transmission of patient data allowing physicians to continuously monitor patient cardiac events remotely.

Mark S. Gorder, president and chief executive officer at IntriCon says, "With rising health care costs, we are excited to offer a device that will not only improve patient quality of life, but also reduce treatment costs by providing the ability to identify asymptomatic cardiac events remotely. The Centauri follows current industry trends of shifting patient care from expensive health-care settings to the home which not only reduces costs but improves patient comfort."

The Centauri device provides diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. With continuous monitoring, automatic arrhythmia detection and wireless transmission of the recorded cardiac activity to a licensed physician for review, Centauri offers flexibility and comfort not found in traditional devices.

Given the timing of the FDA clearance, IntriCon expects to release the product in the third quarter of 2011 and anticipates modest revenue contributions in the 2011 fourth quarter.