Medtronic to test device that combines implantable defibrillator with heart monitoring

By Elaine Rigoli

Tampa, Fla., May 9 - Medtronic, Inc. announced the launch Tuesday of a landmark clinical trial for a new heart-failure device that combines the capabilities of an implantable cardioverter defibrillator (ICD) with a new technology that continuously records pressure inside the heart and can alert physicians to potential heart-failure complications before they worsen.

The investigational device, known as the Chronicle ICD, features both the traditional ICD's ability to restore normal heart rhythm following a dangerously fast heartbeat and the first real-time tracking of pressure inside the heart, body temperature, patient activity and heart rate 24 hours a day, the company said in a news release.

Patients implanted with a Chronicle ICD will transmit that information from home, using a standard phone line, to their physicians who view the recorded data from a secure web site in their office and then potentially make changes to patients' medications or diet.

The study seeks to determine the safety, efficacy and functionality of the Chronicle ICD when used in heart-failure patients indicated for ICD therapy. Sponsored by Medtronic, the blinded study is a prospective, randomized, multi-center clinical trial at up to 75 sites in the United States involving about 850 patients with mild to moderate heart failure, the release said.

Medtronic, based in Minneapolis, is a medical technology developer.

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