Press Release

Date:

April 12, 2016

BIOTRONIK, Inc.
6024 Jean Road

Page:

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Lake Oswego, OR 97035-5571 USA

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+1 (800) 547-0394 (24-hour)

Fax +1 (503) 635-9936

www.biotronikusa.com

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 patients anatomy, while
providing unmatched sensing amplitude that ensures reporting
accuracy. BioMonitor 2 also features BIOTRONIKs 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.

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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
BIOTRONIKs 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 worlds 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 worlds first 4 F compatible stent for treating long lesions;
Orsiro*, the industrys first hybrid drug-eluting stent; and the worlds
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.

For more information, visit: www.biotronikusa.com

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US Media Contacts:
Carol Barbre
Vice President, Marketing & Communications
(800) 547-0394, Ext. 8203
(503) 451-8203
carol.barbre@biotronik.com
Stacey Holifield
Levitate
(617) 233-3873
stacey@levitatenow.com