[October 05, 2015] |
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EBR Systems Receives European CE Mark Approval for World's First Wireless Cardiac Pacing System for Heart Failure
EBR Systems, Inc., leading innovator in wireless heart stimulation,
today announced European CE Mark (Conformité Européenne) approval for
its WiSE™ (Wireless Stimulation Endocardially)
Technology.
EBR Systems' WiSE Technology is the world's only wireless endocardial
pacing system for cardiac resynchronization therapy (CRT). CRT is a
treatment for heart failure that uses an implantable pacemaker to
improve the heart's pumping efficiency by synchronizing the left and
right ventricles. Studies have demonstrated successful CRT therapy
reduces heart failure symptoms, hospitalizations and mortality. WiSE
Technology could potentially benefit 1.5 million of these patients
worldwide.
CE Mark approval gives EBR Systems the ability to train and educate
physicians in the European Union on the use of the WiSE System, enabling
more patients to benefit from this innovative therapy. During the next
12 months, EBR Systems will continue working with leading European
clinicians to assess different strategies for optimizing endocardial
pacing location that maximize CRT benefits.
Preliminary results of the recently completed SELECT-LV study were
presented in mid-May by Mt. Sinai Hospital cardiologist and Professor of
Medicine Vivek Reddy, M.D., at the Heart Rhythm Society Scientific
Sessions in Boston. In a study of 35 patients who had failed
conventional CRT therapy, 97% were implanted successfully with WiSE
Technology. Twenty-six of them had reached the six month effectiveness
endpoint, with 81 percent improving their clinical composite score which
is a measure of symptom improvement. Nine patients had not yet reached
the six month follow up.
"A growing body of evidence strongly suggests EBR's WiSE echnology can
benefit patients who have failed conventional cardiac resynchronization
implants," said EBR Systems CEO Allan Will. "We look forward to working
with leaders in the European clinical community to further characterize
the benefits of wireless endocardial pacing."
CRT devices have been shown to improve left ventricular function and
reduce morbidity and mortality in patients with cardiac synchronization
problems. However, conventional CRT devices use wired leads to deliver
pacing pulses to the left ventricle. These wires can break or otherwise
fail, leading to complications in roughly 5-10 percent of cases. The
WiSE Technology is leadless, completely eliminating the need for a
pacing wire in the left ventricle.
In addition, approximately 30 percent of patients receiving conventional
CRT do not respond to the therapy. Data suggests this is largely due to
limitations on where current, market-approved leads can be placed in the
heart's venous anatomy to stimulate the left ventricle.
The financial impact of these issues is profound. More than one billion
dollars out of $3.5 billion spent annually on CRT devices provides no
patient benefit.
EBR Systems' WiSE Technology consists of a tiny electrode implanted in
the left ventricle. With every heartbeat it receives a synchronized
ultrasound signal from a small transmitter placed between two ribs.
Those sound waves are converted to electrical energy, providing cardiac
pacing.
This unique technology eliminates the need for a left ventricular lead
and is designed to let the physician place the stimulation point at an
optimal, patient specific location inside the left ventricle
(endocardially) which may potentially be more effective. Endocardial
stimulation is generally considered more like the natural activation
pattern of the heart than today's epicardial pacing techniques. Data
from multiple sources strongly suggests this can benefit patients and is
a potential major advance in left ventricular stimulation.
WiSE is the world's first and only wireless cardiac pacing system for
heart failure. In June 2015 it was selected Favorite Innovation
winner at the annual EUROPACE CARDIOSTIM congress in Milan, Italy.
About EBR Systems
EBR Systems is dedicated to superior treatment of cardiac rhythm disease
by providing more physiologically effective pacing through Wireless
Stimulation Endocardially
(WiSE). The company's patented, proprietary technology was
developed to eliminate the need for cardiac pacing leads, historically
the major source of complications and reliability issues in cardiac
rhythm disease management. The Company's initial product eliminates the
need for coronary sinus leads to stimulate the left ventricle in heart
failure patients requiring CRT. Future products will address wireless
endocardial stimulation for bradycardia and other non-cardiac
indications.
The Company's wireless pacing system is not currently available for use
in the United States.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151005005540/en/
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