Medtronic (Minneapolis) reported the commercial availability of its Reveal XT Insertable Cardiac Monitor (ICM) in the U.S., along with the nation's first implant of the device. Blair Grubb, MD, a professor of medicine and pediatrics at the University of Toledo Medical Center in Ohio, conducted the procedure.
According to the company, the Reveal XT joins the Reveal DX ICM as the first insertable cardiac monitors that offer comprehensive remote monitoring capabilities via the Medtronic CareLink Network, and which allow doctors to confirm or rule out an abnormal heart rhythm.
"The Reveal XT Insertable Cardiac Monitor is really like a black box in an airplane; it captures vital information 24/7 ... for up to three years," Elizabeth Hoff, VP and general manager of the Subcutaneous Diagnostics and Monitoring unit of Medtronic's Cardiac Rhythm Disease Management business, told Medical Device Daily.
The company said doctors may choose the Reveal XT ICM for 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, the company said.
Hoff said Reveal XT is Medtronic's first and only ICM in the U.S. and the XT is specifically used to diagnose and monitor for up to three years AF, one of the leading causes of stroke. Both the Reveal XT and the Reveal DX can be used in the Syncope populations, she said, but the Reveal XT is primarily used to evaluate AF. Both devices can be used with Medtronic's CareLink Network, Hoff added.
ICMs can have a significant advantage over external monitors, she said, noting that one of the biggest issues with external monitors is poor patient compliance. "One of the advantages of an insertable monitor for something as serious as AF is guaranteed patient compliance for a longer period time."
Hoff said the Reveal XT may be used to diagnose AF in patients, or it may be used in patients with known AF to monitor the length and frequency of episodes. Such information allows the physician to make better treatment decisions, she said. "It's like having your doctor with you 24 hours a day."
"I see many patients desperately seeking answers for their unexplained symptoms," Grubb said. "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, Medtronic said. The patient can store an ECG by placing a hand-held, pager-sized assistant over the device, and pressing 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, according to the company.
"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," Hoff said.
Medtronic received Japanese regulatory approval for the Reveal DX ICM in July. The company said the device provides insight into syncope, unexplained fainting episodes. Syncope is difficult to diagnose as episodes are often too infrequent and unpredictable for detection with conventional monitoring techniques such as ECG Holter monitors or external loop recorders. The Reveal DX ICM is about the size of a memory stick and is capable of monitoring patients for up to three years (Medical Device Daily, July 21, 2008).
Medtronic is not alone in the ICM sector. In September, St. Jude Medical (St. Paul, Minnesota) reported FDA clearance of its Confirm ICM, a device the size of a computer thumb drive designed to provide more accurate sensing of the heart signals. St. Jude said at the time that it is the smallest cardiac monitor available. St. Jude's device also is approved for syncope (MDD, Sept. 12, 2008).
Another Minnesota company in this sector is Transoma (also St. Paul), which rolled out its Sleuth implantable monitoring system in 2007, which is designed to provide continuous monitoring for diagnosis of syncope.
The Sleuth, a thin device about the size of a 50-cent piece, is placed under the skin near the shoulder. It is designed to continuously gather ECG data, and then automatically and regularly forward 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 doctor (MDD, Oct. 31, 2007).