BERLIN--(BUSINESS WIRE)--BIOTRONIK today announced the market release of its new injectable cardiac monitor (ICM), BIOMONITOR III, following approval in the CE region. The novel device is designed to help patients with irregular heart rhythms by documenting suspected arrhythmia or unexplained syncope with increased clarity.
As the most common type of arrhythmia, 33.5 million patients worldwide suffer from atrial fibrillation (AF).1 It is associated with a five-fold increase in risk of stroke, a three-fold increase in incidence of congestive heart failure, and higher mortality.2 Aiming to improve the accuracy of arrhythmia detection and diagnosis, BIOTRONIK’s new ICM offers increased signal quality.3
“What I like about BIOMONITOR III is the ease of use and the high signal fidelity,” said Associate Professor Paul Gould, cardiologist and electrophysiologist at St Andrew’s War Memorial Hospital, Brisbane, Australia. “This coupled with the automatic Home Monitoring, provide an excellent resource to establish a rhythm symptom correlation or to detect occult arrhythmias in my patients."
BIOMONITOR III’s unique BIOvector is designed to deliver high definition signals. As a result, the high signal amplitudes and visibility of the p-waves3 make it easier for the physician to confidently evaluate arrhythmias.
BIOTRONIK’s next generation ICM is 60% smaller than its predecessor, BioMonitor 2, and comes ready to inject, with the device pre‑assembled in a one-piece injection tool. To optimize patient comfort, BIOMONITOR III offers a very small size and flexible sensing antenna. The device is injected under the skin with a very small incision, facilitating in‑office treatments.
BIOMONITOR III works with BIOTRONIK’s fully automated, ‘plug in and go’ Home Monitoring. Due to automatic pairing, initialization and data transmission no active patient involvement is required. The new product also features Intelligent Memory Management, which prevents the overwriting of clinically relevant episodes. Thus, no relevant information is missed.
“We developed BIOMONITOR III to bring an injectable diagnostic solution with clear signal quality to the market,” commented Dr. Alexander Uhl, Senior Vice President Corporate Marketing at BIOTRONIK. “Working with an ICM should be easy, efficient and in-office-friendly – BIOMONITOR III is exactly that. With all its features, our new monitor reliably provides physicians with the needed information in high quality on the patient’s condition to avoid health risks associated with arrhythmia.”
1 Chugh SS et al. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 study. Circulation, 129 (2014):837-847.
2 Camm AJ et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012;33(21):2719–2747.
3 BIO|CONCEPT.BIOMONITOR III Study. Data on file.
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.