Medical technology firm Biotronik has secured approval from the US Food and Drug Administration (FDA) for its next-generation injectable cardiac monitor (ICM) called Biomonitor III.
Image: Biomonitor III is the next-generation injectable cardiac monitor. Photo: courtesy of BIOTRONIK.
Biomonitor III has been developed to determine suspected arrhythmia or unexplained syncope with increased clarity, facilitating quick diagnosis and appropriate treatment.
According to the company, early detection of arrhythmia through ICMs allows physician intervention before adverse outcomes occur, and atrial fibrillation (AF) is the most common type of arrhythmia that contributes to over 130,000 deaths each year.
Biomonitor III, which is smaller than its predecessor, is pre-loaded in an injection tool, requires no assembly and significantly simplifies the insertion process.
The single-piece injection tool will improve the application in a variety of clinical settings, including office-based procedures.
The next-generation injectable cardiac monitor will also decrease case times and reduce procedural costs, said the company.
Biotronik’s new ICM also provides increased signal quality, enabling to enhance the accuracy of arrhythmia detection and diagnosis. Biomonitor III is also provided with a patient app to support patient-provider engagement.
The new cardiac monitor also features intelligent memory management to protect and deliver the most relevant detections and enhance diagnostic workflow performance.
The ICM is fully integrated with the firm’s fully-automatic and , daily remote monitoring system, as well as features exclusive BIOvector design.
Approved as MR conditional for both 1.5T and 3.0T applications, the Biomonitor III also uses lossless compression algorithm to maintain high amplitude signal quality.
Biotronik president Ryan Walters said: “Receiving FDA clearance on BIOMONITOR III further demonstrates BIOTRONIK’s continued dedication to designing innovative technology solutions that improve patient lives.
“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.”
Based in Berlin of Germany, Biotronik is engaged in the development of advanced cardiovascular and endovascular solutions.