First Use Of New Subcutaneous Heart Monitor

Main Category: Medical Devices / Diagnostics
Also Included In: Heart Disease
Article Date: 16 Feb 2009 - 9:00 PST

email to a friend   printer friendly   view / write opinions

Medtronic, Inc. (NYSE: MDT) today announced the commercial availability of its Reveal XT™ Insertable Cardiac Monitor (ICM) in the United States, along with the nation's first implant of the new device. The procedure was conducted by Blair Grubb, M.D., professor of Medicine and Pediatrics at the University of Toledo Medical Center, a renowned heart specialist. The Reveal XT device joins the Reveal® DX ICM as the industry's first insertable cardiac monitors that offer comprehensive remote monitoring capabilities, via the Medtronic CareLink® Network, and which allow physicians to confirm or rule out an abnormal heart rhythm.

Physicians may choose the Reveal XT insertable cardiac monitor for their patients with suspected arrhythmias, and in difficult-to-diagnose patients for whom long-term cardiac rhythm trending data may aid in a more informed diagnosis. The Reveal XT device is also an option for physicians seeking to detect the presence of atrial arrhythmias (irregular heart rhythms in the upper chambers), including asymptomatic episodes, or to monitor the amount of time a patient is in atrial fibrillation (AF) to assess whether medical treatment is necessary or should be adjusted.

"I see many patients desperately seeking answers for their unexplained symptoms," said Dr. Grubb. "By adding AF detection capabilities and greater diagnostic reporting, I expect the Reveal XT device to be an even more effective tool to help monitor and diagnose my patients' cardiac conditions."

Placed just under the skin of the chest area in a short outpatient procedure, the Reveal XT and DX devices capture an electrocardiogram (ECG) during the actual episode; to store an ECG, a patient places a hand-held, pager-sized assistant over the device, and presses a button. Later, a physician analyzes the stored information, transmitted via the Medtronic CareLink Network or during an in-office patient visit, and determines whether the episode was caused by an abnormal heart rhythm. Reveal device data has been accessible via the Medtronic CareLink Network since fall 2008, which allows patients to stay connected to their healthcare provider from home and offers physicians access to diagnostic data remotely, which may help them make timely, informed decisions.

"The Reveal XT monitor offers physicians a proven option for uncovering dangerous cardiac conditions, including atrial fibrillation. For patients experiencing arrhythmias or unexplained fainting episodes, having greater insights into the cause is incredibly valuable for both the patient and physician," said Elizabeth Hoff, vice president and general manager of the Subcutaneous Diagnostics and Monitoring unit of the Cardiac Rhythm Disease Management business at Medtronic. "Introducing the Reveal XT device expands the market-leading position in cardiac diagnostics and monitoring devices that Medtronic has held for more than 10 years."

Key Facts About Arrhythmias and Syncope

- Arrhythmias are simply irregular heart rhythms in the heart's atria (upper chambers) or ventricles (lower chambers).

- They can be dangerously fast heart rhythms, known as tachycardia or tachyarrhyhmias; dangerously slow rhythms, known as bradycardia or bradyarrhythmias; fibrillation, where the heart quivers instead of pumping blood effectively to the body; or asystole, which is the absence of electromechanical activity within the heart.

- AF is the most common irregular heart rhythm condition, found in approximately three million Americans and seven million people worldwide1.

- Syncope accounts for one to six percent of hospital admissions2 and one percent of total ER visits3 per year.

About Medtronic

Medtronic, Inc., headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

1. Millennium Research Report; "Global Markets For Atrial Fibrillation Treatment Devices 2008," March 2008; 1.

2. Kapoor W. Evaluation and outcome of patients with syncope. Medicine (Baltimore). May 1990;69:160-175.

3. Brignole M, et al. Management of syncope referred urgently to general hospitals with and without syncope units. Europace. 2003;5:293-298.

Medtronic