The company presented the data on its next-generation long-term continuous monitoring (LTCM) patch ECG device at Heart Rhythm Society’s HRX 2024 meeting.
Zio builds on the previous-generation Zio XT with long-term, continuous cardiac monitoring for up to 14 days. It provides an end-to-end experience for patients with potential arrhythmias and demonstrates 99% patient compliance. iRhythm launched the next-generation monitor in the U.S. in September.
iRhythm also kicked off the launch of its Zio monitoring service in Austria, the Netherlands, Spain and Switzerland last month. The technology, along with the supporting Zeus AI algorithm, picked up CE mark at the start of the year.
The real-world data presented at HRX by iRhythm compared post-market performance for Zio against the previous-generation Zio XT. Zio demonstrated fewer earlier wear terminations, longer wear duration and longer analyzable time compared to Zio XT. It also delivered a greater yield of paroxysmal AFib and overall arrhythmia detection than the previous generation.
“Not all ambulatory cardiac monitoring services are the same. We first learned that in the CAMELOT study,1 where Zio XT provided greater diagnostic yield and less retesting than other monitors,” said Dr. Rod S. Passman, cardiac electrophysiologist, professor of medicine at Northwestern University and presenting author. “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.”
More on the iRhythm next-gen Zio data
Researchers retrospectively compared U.S. real-world data from patients using the two LTCM services. The analysis period corresponded to the initial launch of Zio and included 14-day prescriptions between May 2022 and September 2023. That comprised 7,433 Zio monitors and more than 1.3 million Zio XT devices.
The new Zio LTCM service registered 1.1% early wear terminations, compared to 2.8% with Zio XT. iRhythm also received fewer skin irritation reports (0.47% vs 1.35%) for Zio compared to Zio XT. The yield of paroxysmal AFib (8.7% vs. 6.8%) and overall arrhythmia detection (80.9% vs. 76.4%) also favored Zio.
“Prior studies have already demonstrated high wear time, high analyzable time,6 high diagnostic yield and less retesting of Zio XT,1” said Dr. Mintu Turakhia iRhythm’s chief medical and scientific officer and EVP, product innovation. “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.”
