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.

Icentia Launches CardioSTAT® Wire-free Cardiac Monitoring Wearable Device in Canada

Today announced the Canada-wide launch of the CardioSTAT® device, the first wearable, long-term ambulatory cardiac monitor available in Canada. At 20 grams and 5 mm, the device weighs as little as AA battery and is as thin as the average USB drive. Designed to be worn invisibly under clothing on the upper chest, patients can use this water-resistant cardiac recorder during daily activities including exercise and showers. As a result, superior patient compliance makes it easy for doctors to monitor patients for longer periods, thus increasing the detection rate of heart rhythm problems.

“CardioSTAT allows us to get heart rhythm recordings over several days. The device is well tolerated by patients, which can prove difficult to obtain with conventional equipment. With several day's worth of uninterrupted data, we are now able to make better diagnoses,” said Dr. Jean Champagne, cardiac electrophysiologist at the Quebec Heart and Lung Institute.

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.

Learn more about CardioSTAT at www.cardiostat.com

Icentia Announces Health Canada License for its CardioSTAT®

Icentia announced that its CardioSTAT® has obtained a Class II Medical Device Licence from Heath Canada. Developed in cooperation with cardiologists at the Quebec Heart and Lung Institute (ICUPQ), CardioSTAT® is a unique electrocardiography monitoring device for patients with suspected cardiac arrhythmia. It enables healthcare institutions to manage higher volumes of ambulatory ECG tests, while providing their patients with a greatly improved experience.

Included in CardioSTAT® indications is atrial fibrillation (AF), the most common cardiac heart arrhythmia. AF increases the risk of potentially disabling or deadly ischaemic stroke. It is estimated that atrial fibrillation affects 1 to 2% of the Canadian population and those numbers are predicted to increase due to an ageing population. Of even greater concern, there is evidence that this condition is often unrecognized by both clinicians and patients and it is therefore significantly under-diagnosed. By facilitating the access to simpler and more efficient diagnostic tests, Icentia hopes to help physicians perform earlier and better diagnosis, consequently helping them provide optimal care and save lives.

With this first addition to its medical test platform, Icentia is extremely proud to finally be able to offer patients the benefits of years of hard work. While the deployment of CardioSTAT® takes place among hospitals across the country, Icentia will pursue its mission of helping healthcare institutions become more efficient with the development of additional medical test solutions.

Icentia Achieves ISO 13485 Certification for Medical Devices

Icentia announces that it has received certification from the British Standards Institution (BSI) that its quality system meets the ISO 13485:2003 standard for medical device product.

Beginning of 2014, Icentia embarked on an effort to enhance its quality and manufacturing capabilities to the level necessary to meet the regulatory requirements for manufacturing of medical devices. On April 30th, BSI certified Icentia as meeting all the requirements of the standard.

“Obtaining the ISO 13485 certification in such a short period of time is a clear demonstration of the talent and strong teamwork of all our employees.” states Pierre Paquet, Icentia co-founder and CEO. “Achieving this important milestone constitutes a key step toward obtaining the Health Canada Medical Device License for the CardioSTAT®.”

ISO 13485 is the world’s most recognized standard for quality management systems for medical devices. Obtaining the ISO 13485 certification is the most commonly chosen path for companies to meet the quality system requirements necessary to manufacture medical devices in Europe, Canada, Japan, Australia, and other countries.

BSI is one of the world’s largest and most trusted independent certification bodies for quality management systems.

Icentia enrolls the first patient in its 300-patient, multicenter clinical study

Icentia is pleased to announce that the first patient was officially enrolled in its 2-year, 300-patient, multi-center clinical study to evaluate the CardioStat, a unique electrocardiography monitoring solution for patients with suspected cardiac arrhythmia.

This study is the result of a collaboration between Icentia and the Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) who have chosen to join their efforts in July of 2012 to test the CardioStat solution. The study follows a protocol formally approved by the IUCPQ ethics committee on June 2013 (approval #20898).

The Principal Investigator for this study is cardiologist Dr Isabelle Nault from the IUCPQ. Dr Nault also benefits from a collaboration with 6 cardiologists from the same institute. This study was made possible with the financial support of the Fondation de l'IUCPQ.

Icentia receives support from the National Research Council of Canada

Icentia Inc. is pleased to announce it will obtain the support from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) to develop its CardioStat suite of cardiology products and services. Icentia welcomes the advisory services and the financial support provided by NRC-IRAP as it will surely help accelerate the launch of the first CardioStat commercial version.

For more information about IRAP: http://www.nrc-cnrc.gc.ca/eng/irap/services/index.html

Icentia receives authorization from Health Canada to distribute the CardioStatTM in the context of its experimental study

Icentia has obtained authorization under the Medical Devices Regulations of Canada for the sale of the CardioStat in the context of the experimental study it is conducting with the Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ).

Icentia and IUCPQ are collaborating in this study to evaluate the performance of the CardioStat electrocardiography monitor and its efficacy at detecting most common types of atrial arrhythmias. Icentia plans to enrol the first patient of this multicenter, 300-patient study early this summer.