Stroke Prevention: BIOTRONIK Announces FDA Approval of BioMonitor 2 Insertable Cardiac Monitor

Untreated Cardiac Arrhythmia is a Primary Cause of Stroke and Congestive Heart Failure. New Cardiac Monitor Improves Diagnosis of Infrequent Arrhythmias and Syncope.

LAKE OSWEGO, Oregon, April 12, 2016 – BIOTRONIK, a leader in cardio- and endovascular medical technology, today announced Food and Drug Administration (FDA) approval of BioMonitor 2, an insertable cardiac remote monitor with ProMRI® technology.

BioMonitor 2 is designed to provide physicians with the ability to accurately detect and diagnose atrial fibrillation, ventricular tachycardia and fibrillation, and syncope. The device can also be used to monitor atrial events in patients who have undergone ablation procedures.

"The clinical and economic burdens of stroke are high and continue to grow. Prevention is necessary, yet more than 35 percent of strokes are cryptogenic and occur with no known cause,” said Dr. Mark Richards, PhD, MD, FACC, FHRS, Arrhythmia and Cryptogenic Stroke Programs, Promedica Heart & Vascular Institute. “The fast and accurate detection of clinically relevant atrial arrhythmias in these patients is critical to administering therapy that minimizes risk of recurrent stroke. New diagnostic technologies, such as those found in the BioMonitor 2, can help manage these high-risk patients more effectively and efficiently."

A recent Australian pilot study showed greater than 90 percent transmission reliability for daily BIOTRONIK Home Monitoring® transmissions, exceeding proven patient compliance1. In addition, BioMonitor 2 has a capacity of more than 60 minutes of electrocardiogram (ECG) recording time and Intelligent Memory Management ensuring that the most relevant events are always available for review. BioMonitor 2 can transmit up to six subcutaneous ECGs daily via BIOTRONIK Home Monitoring.

BioMonitor 2 is inserted subcutaneously through a minimally invasive process under local anesthesia. The device provides a flexible antenna and positioning, adapting easily to a patient’s anatomy, while providing unmatched sensing amplitude that ensures reporting accuracy. BioMonitor 2 also features BIOTRONIK’s ProMRI technology, ensuring patients have access to full-body magnetic resonance imaging (MRI) scans (both 1.5T and 3.0T) as needed throughout their lifetime.

“Accurate diagnosis is the first step towards saving and improving patient lives. Too many patients suffer from undiagnosed heart conditions that lead to traumatic events including stroke and heart attack,” said Marlou Janssen, President, BIOTRONIK, Inc. “BioMonitor 2 simplifies the diagnosis of inconsistent and potentially life-threatening arrhythmias for physicians and patients. The easy insertion process and continuous wireless monitoring help ensure patient compliance while providing accurate data for physician diagnosis. This innovative technology further underscores BIOTRONIK’s commitment to delivering cardiac technology that safely and effectively enables patients to live life to the fullest.”

  1. Varma N, et al. Eur Heart J. 2014, (37) 12.
  2. Investigational Device: Limited by U.S. law to investigational use.


At BIOTRONIK, patient well-being is our top priority and has been for 60 years. BIOTRONIK is a leading global medical technology company with products and services that save and improve the lives of millions suffering from heart and blood vessel diseases as well as chronic pain. Driven by a purpose to perfectly match technology with the human body, we are dedicated innovators who develop trusted cardiovascular, endovascular and neuromodulation solutions. BIOTRONIK is headquartered in Berlin, Germany, and is represented in over 100 countries.