A Medical Device Daily
Transoma Medical (St. Paul, Minnesota) reported that the first U.S. patients have received its Sleuth implantable ECG monitoring system, the procedure performedby John Hummel, MD, at the Ohio State University Medical Center (Columbus).
The company received FDA clearance on Oct. 1, and a phased U.S. launch will introduce the product to physicians for patients experiencing infrequent, unexplained syncope.
The Sleuth, a thin medical device about the size of a 50-cent piece (or the smallest pacemakers), is placed under the skin near the shoulder. The device continuously gathers ECG data, and then automatically and regularly forwards it to a monitoring center operated by Mednet Healthcare Technologies where cardiac technicians review the information and send reports of relevant cardiac event data to the physician. The Sleuth is wireless, and technicians at the monitoring center automatically receive patient data enabling them to identify irregularities.
“We based the Sleuth ECG system on our implantable wireless remote monitoring technology platform that has played an important role in the development of pharmaceuticals and medical devices for more than two decades,” said Brian Brockway, Transoma Medical CEO and chairman. Hummel added: “The wireless system and long data storage cycle will provide me with the ECG information to potentially diagnose unexplained events accurately, regardless of the patient’s activities or whereabouts.”