FDA Clears Heart Rhythm Testing System

Cambridge Heart Inc. (Bedford, MA) has received FDA clearance to market its HearTwave system for the prediction of life-threatening heart rhythm disturbances and sudden death via the measurement of Microvolt T-wave Alternans. The company expects to begin shipments of its new product during the third quarter of 2000.

The test measures extremely subtle beat-to-beat fluctuations in a person's heartbeat called microvolt T-wave alternans. These tiny heartbeat variations—measured at one millionth of a volt—are detected using proprietary Alternans sensors while the heart rate is elevated by exercise, use of pharmacological agents, or pacing.

The system allows physicians to perform the Alternans test without having to replace their existing stress test system.

"The requirement that customers replace their installed stress test system with our more sophisticated CH2000 Alternans system in order to obtain Alternans testing capability has been an impediment to the penetration of T-wave alternans in the marketplace," stated Jeffrey M. Arnold, chairman, president, and CEO. "In many cases hospitals have elected to standardize with the equipment of one stress test manufacturer, whose products are often networked into the hospital computer systems. The HearTwave system allows the hospital to continue to use their brand of choice for stress tests while adding alternans testing capability, without disrupting their normal stress testing routine. This is a significant milestone achievement for Cambridge Heart."

Edited by Ursula Jones