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

New Cardiac Monitoring Device Helps Doctors Find Hard to Detect Cardiac Rhythm Problems
Icentia Inc. 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 days’ 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.  

Icentia Announces Health Canada License for its CardioSTAT®

Icentia announced that its CardioSTAT® has obtained a Class II Medical Device Licence from Health 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 unrecognised by both clinicians and patients and it is therefore significantly underdiagnosed. 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, multicenter clinical study to evaluate the CardioStatTM, a unique electrocardiograpy 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 CardioStatTM 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.