iRhythm Technologies, Inc., a leading digital health care solutions company focusing on the advancement of cardiac care, has secured a CE mark (Conformite Europeenne) for the ZIO Service, enabling the company to market its long-term continuous heart monitoring solution in Europe.
The company also announced its first international market entry through an exclusive agreement with CardioLogic Ltd, which will make the ZIO Service available to patients throughout the United Kingdom to improve the diagnosis of atrial fibrillation (Afib) and other cardiac arrhythmias. Financial terms were not disclosed.
CardioLogic will market the ZIO Service – which is powered by advanced wearable biosensing technology – to its network of cardiologists and institutions throughout the UK, beginning in December 2014. The ZIO Service is backed by multiple peer-reviewed, published studies and is already recognized as a new standard of care for diagnosing Afib and other cardiac arrhythmias in the United States. Since its commercial launch in 2011, it has been used with over 250,000 patients at nearly 1,000 institutions nationwide.
"We are excited to begin expanding our business internationally, which we believe offers a significant growth opportunity, and in particular, we are pleased that patients and physicians in the UK will now be able to benefit from the ZIO Service," said Kevin King, iRhythm's president and chief executive officer. "CardioLogic is one of the most respected marketers of novel cardiac technologies in the UK. Thus, we believe they are an ideal partner to help drive adoption for the ZIO Service in this growing market."
The ZIO Service consists of three components that work together as a digital cardiac healthcare solution to enable more efficient and cost-effective diagnosis of cardiac arrhythmias. The ZIO XT Patch, with its convenient and easy-to-use design, records and stores all continuous electrocardiography waveforms for analysis when required, facilitating the diagnosis of arrhythmias, which often occur sporadically making them difficult to capture. Proprietary FDA-cleared algorithms are used to analyze the vast data and certified cardiac technicians then review the curated data to ensure delivery of high quality results. Finally, the secure, cloud-based ZIO Report provides physicians with unique, clinically actionable information to enable diagnosis, including the ruling in and ruling out of cardiac arrhythmias, to help guide treatment decisions.
The UK's National Institute for Health and Care Excellence (NICE) recently announced new guidelines to improve treatment for people with Afib, the most common type of heart rhythm disturbance, and thus reduce the risk of stroke. According to NICE, Afib affects approximately 800,000 people in the UK and it is believed that another 250,000 people may be undiagnosed.
"The first step in providing patients with proper treatment for Afib is to ensure that they are properly diagnosed," said Martyn Dixon, managing director of CardioLogic Ltd. "Traditional monitoring techniques have been limited in their ability to detect cardiac arrhythmias because they do not capture enough information or for a long enough period of time. With its consumer-friendly biosensing technology and powerful analytics, the ZIO Service overcomes these limitations to improve diagnosis, with the potential to improve outcomes for the growing number of people affected with this heart rhythm disorder. We believe that, with strong data backing its clinical validity and clinical utility, there will be great demand for the ZIO Service among patients, physicians and hospitals in the UK."
Cardiologic Ltd is a privately held cardiology business specialising in distributing and supporting cardiac rhythm management solutions.