iRhythm Zio Monitor Study Holds Promise for ECG Wearable Innovation
The company reported positive initial findings when comparing the newest long-term continuous monitoring ECG patch to its previous generation.
iRhythm Technologies today unveiled initial findings on the post-market and real-world performance of its Zio monitor, building on the devices previous generation of the long-term continuous monitoring (LTCM) patch ECG, Zio XT. The new generation of the device is designed to be lighter, smaller, and thinner, according to the company.
The Zio devices are used to provide continuous recording of heart activities and include a comprehensive end-of-wear report.
Here’s how it works:
A healthcare provider prescribes a patient the Zio monitor that is then applied to the chest during an office visit or sent home for self-application.
While wearing the monitor, the patient then notes any unusual heart symptoms by pressing the top of the patch and then describing the episode in the MyZio mobile app or symptom log booklet.
Once the prescribed wear time ends, the patient then removes the monitor, buts it and the log booklet back in the same box it came in and drops the package into any USPS mailbox.
iRhythm then analyzes the heart data and generates a clear and complete report for the prescribing healthcare provider, who then discusses the results with the patient.
The Zio monitor study, titled “Performance of a Novel Next-Generation Ambulatory ECG Long-Term Patch Monitor: A Multicenter Post-Market Evaluation,” retrospectively compared United States real-world data from patients using iRthythm’s prior generation Zio XT service and the next-generation Zio monitor service, which are both available for commercial use.
Starting the analysis period to correspond with the initial launch of Zio monitor, the study included 14-day prescriptions between May 2022 and September 2023, totaling 7,422 Zio monitors and 1,336,391 Zio XT devices.
The company reported initial findings compared to the previous generation that demonstrated the Zio monitor had:
Fewer early wear terminations (wear time ≤ 48 hours; 1.1% vs 3.8%, p < 0.0001)
Longer average wear duration (12.6 ± 2.7 vs 11.9 ± 3.4 days, p < 0.0001)
Longer average analyzable time (12.2 ± 2.8 vs 11.5 ± 3.5 days, p < 0.0001)
Fewer reports of skin irritation (0.47% vs 1.35%, p < 0.0001)
Additionally, according to unadjusted analyses, Zio monitor showed a greater yield of paroxysmal AF (8.7% vs 6.8%, p < 0.0001) and overall arrhythmia detection (80.9% vs 76.4%, p < 0.0001).
“Prior studies have already demonstrated high wear time, high analyzable time, high diagnostic yield and less retesting of Zio XT,” said Mintu Turakhia, MD, iRhythm’s chief medical and scientific officer and EVP, product innovation, in the press release announcing the study findings. “This new data goes one step further and show how our newest long-term continuous Zio monitor patch performs even better in the real-world.”
In one such previous study called Camelot, Zio XT showed greater diagnostic yield and less retesting than competitor monitors, said Rod S. Passman, MD, MSCE, cardia electrophysiologist, professor of medicine at Northwestern University and one of the Zio monitor study authors, in the release, adding that “Now, we are seeing the impact of design enhancements on device performance, with even better wear time and analyzable time with the new device. Taken together, these advancements could contribute to better patient compliance and higher arrhythmia detection rates.”
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