iRhythm Unveils Data Demonstrating Superior Real-World Performance of Next-Generation Zio® ...

• iRhythm’s next-generation Zio®monitor demonstrated longer wear duration and analyzable time compared to the prior generation Zio®XT device.
• Longer wear duration and analyzable time may further improve diagnostic yield, building upon Zio XT service’s superior yield among ambulatory cardiac monitoring services as demonstrated by the prior CAMELOT study findings.1
• The Zio monitor ECG device has been worn by over 1 million patients since launching in late 2023.2
  

SAN FRANCISCO, Sept. 09, 2024 (GLOBE NEWSWIRE) --   iRhythm Technologies, Inc. (NASDAQ:IRTC) today announced initial research findings on post-market, real-world performance of Zio® monitor, its next-generation Zio® long-term continuous monitoring (LTCM) patch ECG device, presented at the  Heart Rhythm Society ’s HRX 2024 meeting.

Building on the high performance of its previous generation Zio® XT device, the Zio LTCM monitor was designed to be smaller and lighter,3 with a waterproof housing and a new breathable adhesive. 4,5 For the study, titled “ Performance of a Novel Next-Generation Ambulatory ECG Long-Term Patch Monitor: A Multicenter Post-Market Evaluation,” the investigators sought to determine whether these design enhancements translated into improved, post-market real-world device performance compared to its predecessor.

The investigators compared U.S. post-market real-world data of iRhythm’s next-generation Zio monitor to its prior generation Zio XT device. The new Zio monitor demonstrated fewer early wear terminations (i.e., wear time ≤48 hours; 1.1% vs 2.8%, p<0.0001), longer wear duration (average 12.6 vs. 11.9 days, p<0.0001), and longer analyzable time (average 12.2 vs 11.5 days, p<0.0001) compared to the prior generation Zio XT device. In unadjusted analyses, there was 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) with Zio monitor.

“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 Rod S. Passman, MD, MSCE, 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.”

Figure 1 - Zio monitor LTCM patch ECG device by iRhythm Technologies

About the “Performance of a Novel Next-Generation Ambulatory ECG Long-Term Patch Monitor: A Multicenter Post-Market Evaluation” study
Authors:   Bradley P. Knight, Vladimir Fokin, Jeffrey Ellis, Oussama M.Wazni, Rod S. Passman, Mintu P. Turakhia, Suneet Mittal

Researchers retrospectively compared U.S. real-world data from patients using two long term continuous monitors monitoring (LTCM) services, iRhythm’s prior generation Zio XT service and its next-generation Zio monitor service, both available for commercial use. The analysis period corresponded to the initial launch of Zio monitor and included 14-day prescriptions between May 2022 and September 2023, comprising 7,433 Zio monitors and 1,336,391 Zio XT devices. The new Zio LTCM service demonstrated fewer early wear terminations (i.e., wear time ≤48 hours ; 1.1% vs 2.8%, 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), and fewer reports of skin irritation (0.47% vs 1.35%, p<0.0001) compared to the prior generation Zio XT. In unadjusted analyses, there was 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) with the new LTCM service.

“Prior studies have already demonstrated high wear time, high analyzable time,6 high diagnostic yield and less retesting of Zio XT,1” said Mintu Turakhia MD, 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.”

In addition to the new research presented, Mintu Turakhia, MD, MAS, iRhythm Chief Medical and Scientific Officer and EVP, Product Innovation, and HRX Founding Co-Chair in 2021, also participated in the following HRX events:

• What is New About Our Old Tools in Electrophysiology?  – HRX Concurrent Sessions, September 6
• Standards Development for Wearables – Beginning the Discussion – HRX Roundtables, September 7
• HRX Pitch Competition – Panel Judge, September 5 and 7
  

The research findings and thought leadership participation at HRX underscore iRhythm’s commitment to innovation, patient-centered design, and rigorous clinical evidence. To learn more about iRhythm, please visit https://www.irhythmtech.com/.

Since launching the next-generation Zio LTCM monitor and enhanced Zio service in the U.S. in September 2023, the Zio monitor ECG device has been worn by over 1 million patients, representing nearly 70% of iRhythm’s LTCM registrations in the U.S.2 Additionally, iRhythm recently announced the commercial launch of Zio®monitor and Zio®LTCM service in Austria, the Netherlands, Spain, and Switzerland.

iRhythm Technologies sponsored the Performance of a Novel Next-Generation Ambulatory ECG Long-Term Patch Monitor: A Multicenter Post-Market Evaluation study.

About iRhythm Technologies
iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.

Investor Contact
Stephanie Zhadkevich
investors@irhythmtech.com

Media Contact
Kassandra Perry
irhythm@highwirepr.com

1 Reynolds et al. Comparative effectiveness and healthcare utilization for ambulatory cardiac monitoring strategies in Medicare beneficiaries. Am Heart J. 2024;269:25–34. Accessed January 2, 2024. https://doi.org/10.1016/j.ahj.2023.12.002
2 Data on file. iRhythm Technologies, 2024.
3 Data on file. iRhythm Technologies, 2023.
4 Data on file. iRhythm Technologies, 2017, 2023.
5 The Zio monitor patch should not be submerged in water. During a bath, keep the device above water. Please refer to the Zio monitor labeling instructions or Patient Guide for the full set of details.
6 Steinhubl SR, et al. Effect of a Home-Based Wearable Continuous ECG Monitoring Patch on Detection of Undiagnosed Atrial Fibrillation: The mSToPS Randomized Clinical Trial. JAMA. 2018 Jul 10;320(2):146-155.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1f309e78-4eed-4e7b-8423-28efb5cffe7f