FDA Approves BioMonitor 2 Insertable Cardiac Monitor from Biotronik

Biotronik SE & Co. KG, a developer of cardio- and endovascular medical technology, said the  U.S. Food and Drug Administration (FDA) has approved the 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, according to the company.

“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, Ph.D., M.D., FACC, FHRS, Arrhythmia and Cryptogenic Stroke Programs, Promedica Heart and 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 compliance.¹ In addition, BioMonitor 2 has a capacity of more than 60 minutes of electrocardiogram (ECG) recording time and intelligent memory management, ensuring 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 of Biotronik. “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 technology further underscores Biotronik’s commitment to delivering cardiac technology that safely and effectively enables patients to live life to the fullest.”

Biotronik ProMRI technology enables patients with a pacemaker, implantable defibrillator, cardiac monitor, or cardiac resynchronization therapy defibrillator (CRT-D) or pacemaker (CRT-P) to undergo an MRI scan.

Biotronik is based in Berlin, Germany, and has a global workforce of more than 5,600 employees. Its U.S. headquarters is located in Lake Oswego, Ore.

References:

1. Varma N, et al. Eur Heart J. 2014,(37) 12.