iRhythm Announces National Registry Data Demonstrating That Zio(R) Patch Increases Diagnostic Yield in Arrhythmia Detection

Additional Study Demonstrates Zio(R) Patch Monitoring Initiated in Emergency Department Successfully Facilitates Diagnosis; Data Presented at American College of Cardiology's 61st Annual Scientific Session

Marketwired

SAN FRANCISCO, CA and CHICAGO, IL--(Marketwire -03/26/12)- iRhythm Technologies, Inc., a medical device and service company that develops and markets simple, innovative diagnostic monitoring solutions, today announced that positive clinical results regarding its Zio® Patch cardiac rhythm monitoring system were presented at the American College of Cardiology's 61st Annual Scientific Session (ACC.12) in Chicago.

An analysis of ambulatory ECG data from a national patient registry showed that extended monitoring with the Zio® Patch for up to 14 days can increase the diagnostic yield of arrhythmia detection, regardless of the type of arrhythmia experienced by the patient. A separate clinical study conducted in three emergency departments (ED) found that the Zio® Patch facilitated the diagnosis of patients presenting with acute symptoms. Both sets of data were presented during the ACC.12 Moderated Poster Contributions Session titled "Monitoring Arrhythmia Patients: Externally, Via Implanted Devices and Wearable Defibrillators."

"The findings presented at ACC.12 provide additional evidence of the clinical benefits and potential cost-effectiveness of the Zio® Patch cardiac monitoring system," said Judy Lenane, RN, MHA, chief clinical officer of iRhythm. "The results from the national registry, as well as findings from the ED study, are important because they show that longer-duration ECG monitoring beyond 48 hours should be recommended to adequately diagnose arrhythmias, particularly in those in whom the arrhythmias may be causing symptoms. Results of the ED study further demonstrated that the Zio® Patch resulted in accurate arrhythmia detection due to the product's ease of use, which resulted in improved patient compliance. By facilitating the testing for arrhythmias at the point of care, use of the Zio® Patch in the ED may potentially eliminate duplicate testing and reduce healthcare costs."

Poster #1: Clinical Experience and Diagnostic Yield from a National Registry of 14-Day Ambulatory ECG Patch Monitoring
In order to determine the clinical experience and diagnostic predictive value associated with extended-duration ambulatory ECG patch monitoring, Mintu P. Turakhia, M.D., Director of Cardiac Electrophysiology, Palo Alto Veterans Affairs Health Care System, and Instructor of Medicine, Stanford University School of Medicine, and colleagues analyzed data from a national registry of 26,751 patients who wore the Zio® Patch monitor consecutively for up to 14 days.

According to the results of their analysis, the Zio® Patch captured at least one arrhythmia in 60.3 percent of all patients. Average wear time of the device was 7.6 days and the vast majority of patients (95.9 percent) wore it longer than the current standard Holter device (24 to 48 hours). Additionally, in 51.1 percent of patients, their first documentation of symptomatic arrhythmia occurred beyond 48 hours from the start of monitoring. Overall, the analysis showed that extended (up to14-day) monitoring with the Zio® Patch can increase diagnostic yield, regardless of the type of arrhythmia.

Poster #2: Prevalence of Arrhythmias in ED Patients Discharged Using a Novel Ambulatory Cardiac Monitor
In order to determine the prevalence of arrhythmias among discharged ED patients, Ayesha Sattar, D.O., Clinical Instructor, Surgery-Emergency Medicine, Stanford University School of Medicine, and colleagues at Stanford Hospital and physicians from Scott & White Memorial Hospital and Scripps Memorial Hospital applied the Zio® Patch cardiac monitor to 285 ED patients with suspected arrhythmias at discharge. Patients wore the Zio® Patch for up to 14 days.

Analysis of the devices showed that ED personnel could successfully initiate Zio® Patch monitoring and that ED patients were successfully able to utilize the Zio® Patch. Correlation of symptoms with an arrhythmia was able to be made in 7.7 percent of patients and correlation with normal baseline rhythm (rule-out) in an additional 59 percent. By ruling out arrhythmic reasons for symptoms, these patients may not need further arrhythmia testing, thereby potentially averting the need for additional diagnostic testing.

About iRhythm Technologies, Inc.
iRhythm provides innovative and cost-effective diagnostic monitoring solutions that facilitate early diagnosis and treatment decisions, with the goal of ultimately improving patient health outcomes and reducing wasteful healthcare spending. Its flagship product, the Zio® Patch, is designed to optimize and simplify the diagnosis of cardiac arrhythmias. Zio® Patch is the smallest, lightest, least conspicuous cardiac arrhythmia diagnostic available and is indicated for up to 14-day monitoring. For more information, please visit www.irhythmtech.com.

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