SAN FRANCISCO and MARLBOROUGH, Mass., May
6, 2016 /PRNewswire/ -- Boston Scientific (NYSE: BSX)
today announced results from the largest post-market registry for
the Subcutaneous Implantable Defibrillator (S-ICD) System. Data
collected from the EFFORTLESS study were presented as a
late-breaking clinical trial at the 37th Annual Scientific Sessions
of the Heart Rhythm Society (HRS) in San
Francisco, and confirmed long-term safety and efficacy for
the only device available to treat sudden cardiac arrest without
leads touching the heart and vasculature.
The multi-national registry included 985 patients who were
observed for up to five years post-implant – more than any S-ICD
data the company has previously published. Primary results
demonstrate low complication rates associated with the S-ICD
device, with a complication-free rate of 99.7% at 30 days, and
98.0% at 360 days post-procedure.
"We have long believed in the value of eliminating unnecessary
patient complications by choosing a defibrillator which does not
require intracardiac leads," said Lucas V.
A. Boersma, M.D., Ph.D., electrophysiologist at St. Antonius
Hospital, The Netherlands. "This
post-approval registry further confirms that not only is the
Subcutaneous Implantable Defibrillator an effective therapy, but
its benefits are consistent amongst the full range of indicated
patient subsets."
The efficacy of the S-ICD System was further validated in this
analysis, with a 97.4% conversion rate of discrete arrhythmias that
can lead to sudden death.
Follow-up at an average 3.1 years revealed that few S-ICDs were
removed due to a change of patient indication. Only five (0.5%)
S-ICDs were removed in order to implant a patient with a
defibrillator with anti-tachycardia pacing (ATP) capabilities, and
only one (0.1%) was removed to allow for a device with bradycardia
pacing capabilities.
"We are building on the success we've seen with the S-ICD system
by exploring a modular therapy approach that keeps the vasculature
untouched," said Kenneth Stein,
M.D., chief medical officer, Rhythm Management, Boston Scientific.
"We are developing the EMPOWER™ Modular Pacing System, which
includes our leadless pacemaker and the EMBLEM™ S-ICD System.
Whether patients with life-threatening arrhythmias subsequently
develop a need for pacing or vice versa, we are designing this
modular solution to enable electrophysiologists to treat patients
with the therapies they need, when they need them."
Since receiving CE Mark and U.S. Food and Drug Administration
approval for the S-ICD System in 2009 and 2012, respectively,
Boston Scientific launched a next generation EMBLEM S-ICD System
which is 20% thinner and is projected to last 40% longer than the
original S-ICD System. Last month, the company was granted CE Mark
for the new EMBLEM MRI S-ICD System as well as magnetic resonance
conditional labeling for all previously implanted EMBLEM S-ICD
Systems, meaning the devices are considered safe for use in a
magnetic resonance image setting when conditions of use are
met.
For more information on the S-ICD Systems, visit
www.sicdsystem.com.
In the U.S., the EMBLEM MRI S-ICD System and EMPOWER Modular
Pacing System are not available for use or sale.
About Boston Scientific
Boston Scientific transforms
lives through innovative medical solutions that improve the health
of patients around the world. As a global medical technology
leader for more than 35 years, we advance science for life by
providing a broad range of high performance solutions that address
unmet patient needs and reduce the cost of healthcare. For
more information, visit www.bostonscientific.com and connect on
Twitter and Facebook.
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CONTACTS:
U.S. Media: Laura Aumann
Boston Scientific Corporation
(651) 582-4251 (office)
Laura.Aumann@bsci.com
European Media: Simonetta
Balbi
39 010 6060281 (office)
Boston Scientific Corporation
Simonetta.Balbi@bsci.com
Susie Lisa, CFA
Investor Relations
Boston Scientific Corporation
(508) 683-5565 (office)
investor_relations@bsci.com
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SOURCE Boston Scientific Corporation