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New Britain Woman First in State With Wireless Remote Heart Monitoring System

New Britain [April 25 2008] - An 85-year-old New Britain woman is the first in the state and among the first in the nation to be implanted with the Sleuth ECG Monitoring System, the first wireless, implantable system for continuous, long-term monitoring of electrocardiogram (cardiac rhythm) data.

The implantation was conducted April 4 by James St. Pierre, M.D., F.A.C.C., in The Hospital of Central Connecticut’s cardiac catheterization suite. Transoma Medical, Inc., of St. Paul, Minn., manufactures the Sleuth system, which received FDA approval in October 2007.

The system monitors patients suffering from unexplained syncope (fainting), providing accurate, timely diagnostic electrocardiogram (ECG) data to help physicians evaluate cardiac rhythm disorders. The New Britain woman had been experiencing unexplained fainting episodes and was diagnosed with “sick sinus syndrome,” a heart rhythm problem in which the sinoatrial node — the heart’s natural pacemaker — isn’t functioning properly.

Syncope can be caused by a variety of conditions, including metabolic disorders, neurological conditions, emotional distress or multiple cardiovascular conditions, including cardiac rhythm disorders. However, for approximately one-third of syncope patients, standard testing cannot identify a cause. Diagnosing cardiovascular-related syncope can be especially challenging because abnormal heart activity may be infrequent or not apparent to the patient. Conditions causing cardiovascular syncope include heart attack, heart failure, rhythm disturbances, obstructed blood flow and low blood pressure.

With unexplained syncope, many patients must modify daily activities significantly, e.g., stop driving or give up a job, impacting quality of life.

“Patients with unexplained syncope are a challenge to manage,” St. Pierre said. “They are often forced to make significant life adjustments with their careers, families and even driving because their fainting episodes are unpredictable. The Sleuth system provides an entirely new approach in identifying and diagnosing cardiovascular conditions that cause syncope.”

The Sleuth system is a thin medical device about the size of a 50-cent piece (or the size of the smallest pacemakers) placed under the skin near the shoulder. The device continuously gathers ECG data, which show the rate and regularity of heartbeats and provide other information about heart function.
The information is automatically forwarded to a monitoring center where certified cardiac technicians send reports of relevant cardiac event data to the physician.

Standard evaluation of a cardiovascular cause for syncope requires a thorough medical history, physical examination and resting ECG. This may be supplemented by exercise testing, cardiac echocardiography, 24- or 48-hour “Holter” monitoring, a patient-activated cardiac event recorder and implantation of a long-term cardiac monitor.

Other monitoring systems (those with wires and without) require patients to visit their physician’s office periodically to have diagnostic data downloaded. Some wireless systems also require patients to wave a device over the unit when they experience syncope – a problem because not all patients feel a fainting episode coming on. The wireless Sleuth system does not require the patient to wave a device over the unit, and because technicians at the monitoring center constantly review data for irregularities, patients and physicians no longer need to wait for periodically scheduled office visits to obtain diagnostic data.

“The Sleuth system represents a substantial addition to the hospital’s ability to diagnose or extrude elusive cardiac rhythm disorders using remote, online technology,” said Milton Sands, M.D., chief of cardiology at the hospital.

“We are very excited to see physicians adopt our Sleuth system,” said Brian Brockway, Transoma Medical chairman and chief executive officer. “Sleuth is based on more than two decades of experience with our remote wireless diagnostic technology, and we are delighted to make a clinical product available to physicians and their patients.”

Contact: Nancy Martin, 860-224-5900, ext. 4366














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