Proven Cardiac Monitoring Technology Now Made Available to UK Cardiologists; Icentia Launches CardioSTAT Wire-Free Cardiac Monitor System at the Heart Rhythm Congress in Birmingham

Icentia Inc., the leading manufacturer of wearable cardiac monitors in Canada, today announced the UK launch of its CardioSTAT recorder during the Heart Rhythm Congress in Birmingham.

Since its introduction in 2015, CardioSTAT has become the tool of choice for hundreds of cardiologists across Canada for the detection of heart rhythm abnormalities. The CardioSTAT recorder, a flexible, lightweight device designed to be comfortably worn on the upper chest for up to 14 days, is now available to all physicians across the UK through Icentia Ltd, a Yorkshire-based subsidiary of the Canadian leader.

“Having completed tens of thousands of CardioSTAT tests in Canada, we are pleased to offer UK physicians the same high level of efficacy and patient compliance that Canadian physicians have experienced over the years.” says Pierre Paquet, CEO and founder of Icentia Inc. “The increased diagnostic yield of CardioSTAT has led to a significant improvement in clinical outcomes for Canadian patients.”

The CardioSTAT recorder is a thin, flexible strip designed to be invisibly worn under clothing on the upper chest. In a world of wearable devices, it distinguishes itself by providing a level of efficacy similar to the conventional equipment (e.g. Holter). Quick and easy to install, it avoids the inconvenience and discomfort caused by large-surface skin adhesive patches. The result is a highly efficient, yet comfortable and very discrete, wire-free cardiac monitor that can be worn for up to 14 days without restricting patients from showering or doing physical activity.

Icentia Announces CE Mark Approval of the CardioSTAT® ECG Monitoring System

Icentia Inc., a medical device company offering ambulatory medical testing solutions, today announced it has received Class II Medical Device CE Mark approval for its CardioSTAT continuous ECG monitoring system.

The CE marking confirms that the CardioSTAT system meets the requirements of the European Medical Devices Directive, which now allows Icentia to commercialize the CardioSTAT system in the European Union.

“The CE Mark approval is a significant accomplishment for Icentia as it enables the company to expand its market to the European Union member countries,” says Icentia’s CEO, Pierre Paquet.

CardioSTAT is one of the most efficient cardiac monitoring systems available. Since its official launch in 2015, it has become the leader in its class in Canada.

“The extraordinary success of CardioSTAT across Canada clearly demonstrates that we’ve been able to come up with a highly efficient, yet price competitive solution for public healthcare systems” Paquet says. “We now look forward to allowing European patients to benefit from our technology”.

The CardioSTAT recorder is a unique electrocardiography monitoring device designed to be comfortably worn on the upper chest for up to 14 days by patients with suspected cardiac arrhythmia. It enables healthcare institutions to manage higher volumes of ambulatory ECG tests and reduce lead times to diagnosis, while providing their patients with a greatly improved experience. Quick and easy to install, it avoids the inconvenience and discomfort caused by large-surface skin adhesive patches. The result is a highly efficient, yet comfortable and very discrete, wire-free cardiac monitor that does not restrict patients from showering or doing physical activity.

Improved CardioSTAT® Test Will Detect Even More Heart Rhythm Problems

Icentia is proud to introduce an improved version of CardioSTAT which allows for recording durations of up to 14 days. CardioSTAT was launched in 2015 as a 7-day continuous ECG monitor and has quickly become an essential tool across Canada for the detection of heart rhythm problems.

“This extended recording duration opens the door to more accurate and more definitive diagnosis, especially with respect to paroxysmal atrial fibrillation (AF), the most common cardiac heart arrhythmia and a major cause of disabling or deadly ischaemic strokes.” says Icentia’s CEO, Pierre Paquet.

The clinical necessity and cost effectiveness for longer recording duration has been clearly established. Significantly improved rates of detection of atrial fibrillation in stroke and transient ischemic attack patients with multiple-week monitoring have been demonstrated [1,2] and studies strengthen emerging recommendations for prolonged ECG monitoring in secondary stroke prevention [3].

CardioSTAT is a thin, flexible strip designed to be invisibly worn under clothing on the upper chest. Comfortable both day and night, it can be worn during physical activity and in the shower.

 “The development of this new version of CardioSTAT is the result of our collaborative approach with our clients with respect to how we define our products. Physicians know what they need and it’s our role to listen, understand, and provide them with tools that are perfectly adapted to their practice. With this new version, our engineers were not only able to double the recording duration of CardioSTAT, they also reduced the dimension of the electronics by 40%, allowing the recorder to be even more flexible, consequently more comfortable to wear.” says Pierre Paquet.

CardioSTAT was developed by Icentia in collaboration with cardiologists at the renowned Quebec Heart and Lung Institute, a leading Canadian academic medical centre. CardioSTAT is indicated for patients with suspected cardiac arrhythmias requiring continuous cardiac monitoring over several days.

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References:

  1. Gladstone et al., Atrial Fibrillation in Patients with Cryptogenic Stroke

  2. Tommaso Sanna et al., Cryptogenic Stroke and Underlying Atrial Fibrillation

  3. Jean Hai Ein Yong et al., Potential Cost-Effectiveness of Ambulatory Cardiac Rhythm Monitoring After Cryptogenic Stroke 

The CardioSTAT® Monitor Chosen for Long-Term ECG Monitoring for NeuroVISION Study

Dr. Philip J. Devereaux from the Michael G. DeGroote School of Medicine at McMaster University and Dr. Marko Mrkobrada from the Schulich School of Medicine and Dentistry at Western University had the choice of several technologies to conduct their multicentre study attempting to understand the links between noncardiac surgeries and stroke. Among other things, they needed to find an effective, user-friendly method of determining the prevalence of atrial fibrillation (AF) before surgery as well as the incidence of the same arrhythmia after surgery.

For Dr. Mrkobrada, it was the easiest of choices: “After several weeks of use in a clinical context, I have been more than satisfied with the results obtained with CardioSTAT. Due to its ability to record high-quality ECG signals over a long period, it proved to be effective in detecting AF. Moreover, its small size and comfort will facilitate recruiting the hundreds of subjects needed for our study.”

Designed to be invisibly worn under clothing, the CardioSTAT monitor is a thin, flexible strip designed to be worn on the upper chest. Comfortable both at night and during the day, it can be worn during physical activity and in the shower. CardioSTAT enables lengthened monitoring periods extending over several weeks, which increases the detection rate of heart rhythm abnormalities.

NeuroVision is the largest study ever carried out to understand the links between noncardiac surgery and stroke. It is a worldwide study involving centres around the world including London, Hamilton and Vancouver in Canada, Madison WI (USA),  Bangalore (India), Hong Kong, Auckland (New Zealand), Krakow (Poland), Santiago (Chile) and Lima (Peru). 

More information about the NeuroVISION study.