MEDTRONIC INSERTABLE LOOP RECORDER MORE EFFECTIVE.

A study published in a recent issue of the journal Circulation shows that patients who experience recurrent unexplained syncope (fainting) have a greater chance of being diagnosed if physicians use a Reveal Insertable Loop Recorder (ILR).

In the study, 55 percent of patients who received Medtronic's Reveal ILR were successfully diagnosed, while only 19 percent who received conventional testing were diagnosed. Researchers in the Canadian-based study concluded that, "In patients with recurrent unexplained syncope without major structural heart disease, consideration should be given to earlier use of an insertable loop recorder."

In the study, sixty patients with recurrent unexplained syncope underwent a baseline history and physical exam, and an electrocardiogram (ECG) and Holter test. Patients were then randomized to testing with a Medtronic Reveal ILR or to conventional testing with an external loop recorder, tilt test and electrophysiological test. Patients who remained undiagnosed were offered the opportunity to cross over to the other study arm. Study results showed that nearly three times as many patients are diagnosed with the ILR compared to conventional testing. Furthermore, more than three times as many patients were diagnosed with bradycardia using the Reveal ILR.

The study authors concluded that the Reveal ILR should be considered "an early choice" diagnostic tool for unexplained syncopal patients, rather than a last resort after conventional tests have proved inconclusive. "Conventional tests are often ineffective, expensive, and invasive and could leave the patient undiagnosed and at risk for another fainting episode," study author Andrew Krahn, M.D., Division of Cardiology, University of Western Ontario, in Ontario, Canada, said. "Earlier use of the insertable loop recorder can improve the chances of diagnosis compared with conventional tests."

Unexplained fainting (syncope) is a major diagnostic challenge for physicians and a widespread medical concern, accounting for over a million physician visits and more than 170,000 hospitalizations annually. It can lead to bodily injury caused by falls or accidents associated with driving or operating machinery. In addition, individuals who experience syncope may have serious underlying cardiac conditions and may run the risk of increased mortality or morbidity if the condition remains undiagnosed.

The Medtronic Reveal Plus, the second generation ILR, is the only product of its kind on the market. It performs a function similar to that of a "black box" on an airplane, recording important data that can be saved and replayed later to determine a diagnosis. The recorder continuously monitors the heart's electrical activity and records for up to 14 months.

New Indication Cleared by FDA 

While the Medtronic Reveal Plus ILR has been indicated for patients with recurrent unexplained syncope since its release, it was also recently cleared by the FDA for use in patients with clinical syndromes or situations that place them at increased risk for arrhythmias. This new indication allows physicians to use the Reveal Plus ILR to determine whether life-threatening arrhythmias may be present in patients with high-risk conditions.

Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease.

For more information, visit http://www.fainting.com or http://www.seizuresandfainting.com or http://www.medtronic.com or call 763/505-2632.