Icentia Receives U.S. Food and Drug Administration (FDA) Clearance for CardioSTAT®

Quebec City, April 6st, 2023: Icentia Inc., today announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wire free, single-use recorder.

“This approval marks a key milestone for our company. The FDA clearance opens the door to the world’s largest medical device market. With the cost effectiveness and demonstrated ability of our cardiac monitoring solution to provide effective patient care and outcomes, we have no doubts that CardioSTAT will make a meaningful difference in the diagnosis of patients with cardiac disorders in the United States.”, said Pierre Paquet, co-founder and Chief Executive Officer at Icentia.

CardioSTAT has now become the leading wearable cardiac monitoring solution in Canada. Expansion has followed in 2018 with the United Kingdom, where it is experiencing an exceptional adoption rate. To this day, CardioSTAT has been prescribed to more than 170,000 patients. With this clearance, Icentia will be able to pursue its mission of becoming a world leader in ambulatory cardiac monitoring by extending its market to the United States.

The CardioSTAT solution differentiates itself by being the most flexible solution available: physicians have a choice of multiple monitoring durations ranging from 24 hours to 14 days. The pay by duration model enables healthcare professionals to demonstrate cost savings while addressing a wide range of clinical needs. In addition to offering an efficient ECG data analysis service, Icentia also provides the ability for healthcare institutions and diagnostic facilities to benefit from the streamlined workflow of the CardioSTAT single-use recorder while performing the data analysis themselves using Icentia’s cost effective proprietary software.

About CardioSTAT

The CardioSTAT recorder is a flexible, lightweight, and showerproof device designed to be comfortably worn on the upper chest. It can record up to 14 days of data with a compliance rate of 99,9%1. This enables medical practitioners to detect heart anomalies that are generally difficult to identify, such as atrial fibrillation, which affects from 1% to 3% of the world population (up to 9% of people aged over 65 and 17% of people over 80%) and contributes to more than 140,000 deaths per year with stroke being the leading cause of serious long-term disability in the US2.

About Icentia

Icentia is a Canadian medical technology company that develops medical devices and operates cardiac diagnostic testing facilities in Canada and the United Kingdom. It is committed to improving cardiac monitoring and accessibility for both patients and physicians, by offering leading edge solutions to major problems in the field of medical testing.

For more information, please visit:

www.icentia.com

www.cardiostat.com

 References

1.      Internal data collected on more than 90,000 patients, Icentia Inc. 2018-2021

2. Stroke awareness foundation, facts and statistics Stroke Facts & Statistics - Stroke Awareness Foundation (strokeinfo.org)

Icentia supports UKs largest Heart Rhythm Congress

After months of restrictions on face to face meetings, last month, the team at Icentia were delighted to be reunited for the UKs largest exhibition and educational meeting for specialists in the cardiac rhythm management space.

Arrhythmia Alliance organised their annual meeting (HRC 2022) returning the first face to face meeting on this scale in a couple of years due to the COVID-19 pandemic. Supported by global industry representatives, like Icentia, to welcome experts in cardiac rhythms to share best practice, changing protocols, innovative adoption of technology and present their latest clinical research, to an audience hungry for positive patient outcomes that they can take back to their local practice.

Icentia were delighted to be able to participate in this three day event, in central Birmingham, to demonstrate the CardioSTAT ECG patch monitor to interested parties, as well as showcase practical examples of top quality ECG recordings that have changed patients outcomes for the better.

HRC 2022 was a hybrid event, with a vast resource of recorded scientific sessions available online until September 2023. More details can be found by clicking here.

Icentia Supports World Heart Rhythm Week in Parliament

Icentia UK attended the World Heart Rhythm Week parliamentary event, organised annually by the charity, Arrhythmia Alliance, to raise awareness of the patient and healthcare impact of cardiac arrhythmias which affect millions of people across the UK. Attended by members of parliament, physicians, arrhythmia nurses, physiologists and patients and their representatives, with the common interest of raising awareness of arrhythmias. This event saw guest speakers from the UK, US, Germany & Australia who discussed changing practices in arrhythmia management, new technologies to detect arrhythmias early, and best practice in treating Atrial Fibrillation or SCD. Icentia would like to congratulate the winners of the SVT Pioneers of 2022 award for outstanding worldwide research in this area.

The associated campaign to ‘Get To The Heart Of’ was trending amongst the Cardiology Professional and Industry alike to put the spotlight on early detection of arrhythmias to prevent fatal life events for patients. To learn more about this event head to www.worldheartrhythmweek.org for resources.

Icentia are proud to have attended this event and have the opportunity to talk to the heart community about how CardioSTAT has helped HCPs diagnose >135,000 patients through continuously monitoring cardiac rhythms for patients, with our comfortable and discreet monitor.

To request more information CardioSTAT, please click here.

Ambulatory cardiac monitoring: Icentia’s CardioSTAT reaches 100 000 tests

Icentia, a Canadian company that specializes in medical devices, has delivered its 100 000th CardioSTAT test.

For Icentia, such a milestone reflects the relevance of its ambition: Since it launched the test in 2015, it has worked to simplify heart rhythm anomaly detection for patients in Canada and the United Kingdom. As a symbolic aspect of this success, the 100 000th test was recorded with a patient at the renowned Quebec Heart and Lung Institute (IUCPQ), which has partnered with Icentia in the development of this innovation since 2013.

Designed and made in Canada, CardioSTAT is an electrocardiography (ECG) device that enables simple, long-term and high-quality recordings. Worn on the upper chest, it can produce up to 14 days of data. This can enable medical practitioners to detect heart anomalies that are generally difficult to identify, such as atrial fibrillation, which affects from 1% to 3% of the world population (up to 9% of people aged over 65 and 17% of people over 80). Discrete and comfortable, CardioSTAT is a viable alternative for patients and doctors to the conventional test (the Holter test), usually limited to 48 hours. Since the Covid-19 pandemic, patients can also implement the CardioSTAT test directly at home, avoiding hospital visits and reducing contamination risks, as well as the medical staff’s workload.

CardioSTAT is now used by hundreds of health institutions in Canada and the United Kingdom. Icentia and its 120 employees are proud of this international recognition, at a time when the company considers expanding to other countries.

Firmly positioned in a rapidly growing wearable devices industry, Icentia was part of the Globe and Mail’s top growing companies list in Canada for a third consecutive year in 2021. 

“Reaching 100 000 CardioSTAT tests is a great economic success, but especially human, as this milestone means we have helped as many patients. We are working hard to assist many more in the years to come,” says Pierre Paquet, cofounder and CEO of Icentia.

About the Quebec Heart and Lung Institute

The Quebec Heart and Lung Institute (IUCPQ) is a leader in its field. The university hospital offers care, specialized services and ultra-specialized services programs to treat cardiopulmonary diseases and illnesses linked to obesity. More specifically in the field of cardiology, the IUCPQ has the highest clinical volume in tertiary cardiology on a single site in Canada, in addition to pioneering in several other key elements, such as cardiac electrophysiology.

BCUHB NHS Wales – Enabling patient access to ambulatory ECG monitoring with CardioSTAT

CardioSTAT is set to help hundreds of cardiac patients in North Wales gain quicker access to ambulatory ECG monitoring.

In response to reduced clinic space and staffing levels resulting from the COVID-19 pandemic, Betsi Cadwaladr University Health Board (BCUHB) are offering approximately 1,300 patients the opportunity to have CardioSTAT heart monitors sent to them in the post, where they can be fitted at home and then sent off to Icentia for analysis without the patients needing to attend one of North Wales’ three District General Hospitals. 

Dr Richard Cowell, Lead Consultant Cardiologist for BCUHB said: “The new approach would help meet a growing waiting list for ECG monitoring across the region”.  He then went on to say: “There is an increasing number of patients waiting for continuous or prolonged ECG monitoring and some high-risk patients are understandably very worried about attending the hospital.  Typically, these patients will have troublesome palpitations, episodes of dizziness or even blackouts.”

Helen Wilkinson, BCUHB Strategic Manager for Cardiac Services said: “We need to be innovative with our diagnostics whilst keeping our patients safe and introducing this partnership with Icentia is the most obvious solution”.

Buckinghamshire Healthcare NHS Trust partners with Icentia to monitor cardiac patients

CardioSTAT Home Application enables over 1,000 patients in the Buckinghamshire area to gain timely access to ambulatory ECG monitoring through the pandemic.

On 12th March 2020, Buckinghamshire Healthcare NHS Trust (BHT) entered a state of critical incident planning due to the COVID-19 pandemic, with a decision made to defer or cancel all elective outpatient activity. To maintain the arrhythmia service whilst minimising infection risk, a method of ambulatory ECG monitoring for urgent patients with minimal or no hospital attendance was required.

CardioSTAT single-use ambulatory ECG recorders were the preferred choice due to their ‘pay per duration’ pricing structure making them the most cost-effective solution.

The ship-to-patient CardioSTAT home application model continues to enable patients in the BHT catchment area to gain timely access to high quality ambulatory ECG monitoring. It also minimises infection risks for both patients and HCPs alike by reducing unnecessary hospital visits.

Icentia Launch CardioSTAT Home Application in Response to the Coronavirus Pandemic

Icentia roll-out CardioSTAT Home Application to customers up and down the UK enabling patients to receive and fit CardioSTAT monitors in the comfort and safety of their own homes without having to visit the clinic or hospital.  At the end of the prescribed duration, the patient simply posts the CardioSTAT back to Icentia for analysis and the clinically actionable ECG reports are then sent directly to the prescribing healthcare professional. 

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 healthcare professionals 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 healthcare professionals the same high level of efficacy and patient compliance that Canadian healthcare professionals 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, something British patients will now be able to benefit from.”

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. Healthcare professionals 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.

--------------- 

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