FDA OKs BIOTRONIK’s Third-Gen Injectable Cardiac Monitor

BIOTRONIK announced FDA clearance of the BIOMONITOR III injectable cardiac monitor (ICM). BIOMONITOR III is designed to document suspected arrhythmia or unexplained syncope with increased clarity, enabling fast diagnosis and appropriate treatment.
 
Early detection of arrhythmia through ICMs enables physician intervention before adverse outcomes occur. Atrial fibrillation (AF), the most common type of arrhythmia and a leading risk factor for stroke, contributes to more than 130,000 deaths each year.1 The death rate from AF has risen for more than two decades,¹ although up to 80 percent of strokes in people with AF can be prevented.²
 
BIOMONITOR III is 60 percent smaller than its predecessor and comes pre-loaded in an injection tool with no assembly required, significantly simplifying the insertion process.³ The single-piece injection tool is designed for ease-of-use in a variety of clinical settings, including office-based procedures. BIOMONITOR III supports reduced case times and lower procedural costs. BIOTRONIK’s new ICM also offers increased signal quality,⁴ helping to improve the accuracy of arrhythmia detection and diagnosis. BIOMONITOR III will also feature a patient app to support patient-provider engagement. The app reports system diagnostics and offers a method for patients to annotate symptoms with automatic synchronization to BIOTRONIK Home Monitoring.
 
“BIOMONITOR ICMs have a proven track record for exceptional signal quality,” said Dr. Raul Weiss, Columbus, Ohio. “BIOMONITOR III expands the existing diagnostic utility of these devices while simplifying the procedure. BIOMONITOR III is an exceedingly small device with market-leading four year longevity. When physicians are not burdened by poor signal quality, clinically irrelevant data, inaccurate, or worse, missed detections—more time can be devoted to ensuring a timely and accurate diagnosis.”
 
Overwritten ECGs are a common problem in other devices. BIOMONITOR III features Intelligent Memory Management to preserve and deliver the most relevant detections and improve diagnostic workflow performance. The ICM comes fully integrated with BIOTRONIK Home Monitoring—the only fully-automatic, daily remote monitoring system for ICM devices. BIOMONITOR III features BIOTRONIK’s exclusive BIOvector design, a unique hybrid rigid-flexible footprint. The system is designed to improve sensing without sacrifice to patient comfort or cosmetic appearance. BIOMONITOR III also utilizes a lossless compression algorithm to ensure high amplitude signal quality is available anytime via the Home Monitoring system. BIOMONITOR III is approved as MR conditional for both 1.5T and 3.0T applications.
 
“Receiving FDA clearance on BIOMONITOR III further demonstrates BIOTRONIK’s continued dedication to designing innovative technology solutions that improve patient lives,” said Ryan Walters, president at BIOTRONIK Inc. “This device maintains exceptional functionality in detecting arrhythmia and its reduced size and novel delivery tool simplifies the injection procedure. Physicians and patients can count on BIOMONITOR III to deliver timely and accurate data to identify potentially life-threatening cardiac arrhythmias faster and more confidently than ever before.”
 
References
¹ Centers for Disease Control and Prevention. 22 August 2017. https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm 
² National Stroke Association. 2019. https://www.stroke.org/understand-stroke/preventing-a-stroke/afib-stroke-connection/
³ BioMonitor 2 and BIOMONITOR III product specifications. Data on file.
⁴ BIO|CONCEPT.BIOMONITOR III Study. Data on file.