BIOTRONIK Announces FDA Approval of BioMonitor 2 Insertable Cardiac Monitor
LAKE OSWEGO, Ore., April 12, 2016 /PRNewswire/ -- 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."
About ProMRI
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 has the broadest portfolio of cardiac devices approved for use in the MR environment on the market. For more details, please go to www.biotronik.com/promri.
About BIOTRONIK
One of the world's leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including BIOTRONIK Home Monitoring; Pulsar*, the world's first 4 F compatible stent for treating long lesions; Orsiro*, the industry's first hybrid drug-eluting stent; and the world's first implantable cardioverter defibrillators and heart failure therapy devices with ProMRI technology.
References
1 Varma N, et al. Eur Heart J. 2014, (37) 12.
* Investigational Device: Limited by U.S. law to investigational use.
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