BERLIN, July 28, 2021 /PRNewswire/ -- In association with Heart Rhythm 2021, BIOTRONIK today announced that the latest implantable cardiac monitor (ICM), BIOMONITOR IIIm, has been recognized by internationally-renowned research analysts Frost & Sullivan as high-performing across a range of innovation and customer value criteria.
The increased prevalence of cardiac disease, paired with the need to deliver more individualized and efficient healthcare, means that the use of ICMs, which remotely transmit vital clinical data, are now more important than ever. BIOMONITOR IIIm is a miniature electrocardiogram (ECG) device which records, stores and transmits clinical data that is integral in the diagnosis and long-term monitoring of cardiac patients, with maximum precision and for an extended period of time.
The key data ICMs need to deliver are high quality, reliable ECGs that cardiologists can rely upon to support an expedited and accurate diagnosis. BIOMONITOR IIIm's exclusive design is central to providing high rhythm fidelity and detection accuracy due to its high amplitude R-waves that average 0.7mVs and result in noise-free, reliable ECGs.
"This award recognizes that, BIOTRONIK's innovative ICM design—integrating a flexible antenna—delivers superior, high definition ECGs with optimal P-wave visibility and larger signal amplitude," said David Hayes, M.D., Chief Medical Officer, BIOTRONIK, Inc. "Higher amplitudes minimize signal noise to allow uninterrupted cardiac monitoring, enabling healthcare professionals to better diagnose and monitor patients around the clock."
BIOTRONIK's ICM incorporates RhythmCheck®, an algorithm which minimizes the instances of false positive atrial fibrillation (AF) detection. While AF sensitivity remains favorable, at 99.1 percent, while bradycardia, asystole and sudden heart rate drop are maintained at 100 percent, the false detection rate is decreased, helping minimize the clinician workload associated with reviewing non-actionable ECGs in already stretched clinics.
Importantly, BIOMONITOR IIIm is the only ICM with an FDA-cleared vital data sensor which measures patient activity, heart rate and body temperature. The interrelationship between these vital signs and cardiac health conditions is well-documented2. This meaningful digital health innovation can potentially provide earlier detection of infection and facilitates illness screening while patients are still at home, helping to further streamline remote patient management3.
"By allowing patients' recorded cardiac rhythm disturbance to be automatically and wirelessly transmitted to physicians, the solution enables 24-hour monitoring from anywhere. The transmission compliance rate of the BIOTRONIK Home Monitoring solution is 98%, the highest in the industry," said Dr. M. Sneha Maria, Senior Research Analyst at Frost & Sullivan. "Such efficacy is useful, especially during the COVID-19 pandemic, as physicians can continually monitor patients for warning signs without hospital visits."
In its report, Frost & Sullivan also references BIOMONITOR IIIm's industry-leading battery life of five and a half years and how the device's flexible antenna, by design, adapts to the patient anatomy. In addition, it provides a patient-centered remote monitoring experience. These design specifications are some of the unique features which help support a smoother injection with an increased physician and patient experience.
To read the full Frost & Sullivan Enabling Technology Leadership Award report, click here.
References:
- Mariani J et al. BIO|CONCEPT.BIOMONITOR III. Miniaturized implantable cardiac monitor with a long sensing vector (BIOMONITOR III): Insertion procedure assessment, sensing performance, and home monitoring transmission success. Journal of Electrocardiology. (2020).
- Jensen MM, Brabrand M. The relationship between body temperature, heart rate and respiratory rate in acute patients at admission to a medical care unit. Scand J Trauma Resusc Emerg Med 23, A12 (2015). https://doi.org/10.1186/1757-7241-23-S1-A12.
- Hayes, D, Reddy R and Whittington, H. Correlation of Vital Signs Facilitates Illness Screening in an Implantable Cardiac Monitor. BIOTRONIK, Inc., Lake Oswego, OR 2Micro Systems Engineering, Inc., Lake Oswego, ORAPHRS 2020.
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Sarah Lahert
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About BIOTRONIK:
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.
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