Healthcare and technology innovation has far-reaching impacts that can truly transform and save lives. One area of ongoing focus is the growing challenge posed by heart disease. Heart disease is the leading cause of death in the U.S. Someone dies from cardiovascular disease every 33 seconds. These conditions encompass ailments like stroke, heart failure, and notably, atrial fibrillation (AFib). The latter is a rapidly growing issue, projected to affect up to 12 million Americans by 2030.
Diagnostics are vital to detecting heart problems, but traditional cardiac monitoring has had limitations. This note discusses the important advancements of the iRhythm (IRTC) Zio Monitor. iRhythm is a constituent of the Robo Global Healthcare Technology and Innovation Index (HTEC). This index identifies disrupting and emerging technologies in the healthcare sector.
Traditional Cardiac Monitoring Limitations
Many became aware of AFib through smartwatches and their EKG features. Yet clinical diagnosis traditionally relied on methods like Holter monitors, event monitors, and 12-lead ECGs. These tools offered a high level of accuracy. But they often presented challenges regarding patient comfort and the limited duration of monitoring they covered.
For instance, Holter monitors, resembling an early iPod with five wires connected to the body, are typically worn for only 24-48 hours. This not only makes them uncomfortable but also means they might miss sporadic heart events. Event monitors, generally prescribed for 30 days, share similar discomfort issues and require patients to activate them upon detecting a symptom. Standard ECGs, while highly accurate, are performed in-clinic, meaning they can usually only diagnose an arrhythmia if it occurs during that specific visit.
A Modern Solution: Rhythm Zio Monitor
Recognizing this unmet need, back in 2009, iRhythm introduced the Zio long-term cardiac monitor (LTCM). The Zio monitor is engineered for up to 14 days of use, requires no obtrusive leads, and is secured to the patient via a simple patch, while at the same time improving performance. The monitor significantly aids in the earlier detection and management of heart rhythm problems.
Today, iRhythm’s Next Generation Zio Monitor is its smallest, lightest, and thinnest device yet. It incorporates a pioneering deep-learned algorithm, clinically proven to be as accurate as cardiologists in detecting 13 types of arrhythmia classes, along with specific beat types and runs.
Clinical Studies Highlight Zio's Effectiveness
The CAMELOT study, published last year in the American Heart Journal, underscored the benefits of this approach. It revealed that for every 1,000 patients monitored with standard Holter monitors, there was an association with 180 more emergency department visits, 80 additional hospitalizations, and 920 more outpatient visits, when compared to those who used the Zio LTCM service. In other words, the Zio monitor’s earlier, more accurate diagnoses significantly reduced the need for subsequent medical interventions.
Building on this, iRhythm published the AVALON study in April of this year. This landmark real-world comparative evaluation involved 428,770 commercially insured patients with no previous cardiac monitoring history. The findings were compelling. Patients using the Zio LTCM service demonstrated superior outcomes across new arrhythmia diagnoses, reduced need for retesting, and fewer cardiovascular events compared to other ambulatory cardiac monitoring methods.
New Arrhythmia Diagnosis: Baseline Percentages (within 90 days)
As the table indicates, the study found that Zio LTCM users were more likely to secure a new arrhythmia diagnosis than individuals using alternative monitoring devices. In short, the Zio LTCM proved more effective at identifying cardiac issues. Compellingly, Zio LTCM users were also 1.95 times less likely to need retesting within 180 days when compared to those employing other non-iRhythm LTCMs.
Zio LTCM Performance Compared to Other Modalities
Addressing Gaps in Cardiac Care Access
These improved diagnostic capabilities are particularly relevant in addressing “cardiology deserts.” These are areas where patient access to specialized cardiac care is severely limited. Over 46% of all U.S. counties, home to 22 million residents, lack a practicing cardiologist. These regions are typically more rural, face socioeconomic disadvantages, and bear a higher burden of cardiovascular disease. This is exacerbated by the fact that AFib is estimated to be up to three times more prevalent than previously understood, affecting at least 10.55 million American adults.
iRhythm's Growth & Global Expansion
With an established U.S. market penetration of over 30%, iRhythm is now extending its reach internationally. In May of this year, the company announced its launch in Japan, a country where 1.6 million ambulatory cardiac monitoring tests are performed annually. iRhythm is targeting further market opportunities totaling over 5 million tests across EU and APAC countries.
iRhythm’s innovative contributions are recognized by its inclusion in the ROBO Global Healthcare Technology and Innovation Index (HTEC). This index showcases a diversified portfolio of global companies at the forefront of disruptive and emerging technologies in healthcare. The Zio system shares this platform with other leading-edge technologies, including surgical robots, blood-based cancer testing, lab-grown organs, gene-editing therapies and many more ground-breaking advances in health tech.
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HTEC is the underlying index for the Robo Global Healthcare Technology & Innovation ETF (HTEC).
VettaFi is the index provider for HTEC ETF, for which it receives an index licensing fee. However, HTEC ETF is not issued, sponsored, endorsed, or sold by VettaFi. VettaFi and its affiliates have no obligation or liability in connection with the issuance, administration, marketing, or trading of HTEC ETF.
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