New Data Showcases the Long-Term Clinical Benefits of the Nanostim Leadless Pacemaker Compared to Traditional Pacemakers
May 06 2016 - 5:50PM
Business Wire
Three presentations at the 2016 Heart Rhythm Society Annual
Scientific Sessions highlight the retrievability of the Nanostim™
leadless pacemaker, the absence of certain complications associated
with the Nanostim leadless pacemaker vs. traditional pacemakers
with leads, and improved quality of life for patients
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced new data presented at the Heart Rhythm
Society's (HRS) 37th annual scientific sessions that
highlight the long-term safety of the retrievability of the
Nanostim™ leadless pacemaker, the world’s first commercially
approved leadless pacemaker. Two additional presentations also
showed that the Nanostim leadless pacemaker is associated with
reduced rates of acute and mid-term complications compared to
traditional pacemakers with leads and can improve quality of life
for patients. Together these studies add to the growing body of
evidence about the safety and efficacy of the Nanostim leadless
pacemaker.
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New data reveal benefits of the St. Jude
Medical Nanostim(TM) leadless pacemaker design, including its long
term retrievability. (Photo: Business Wire)
The option to be able to retrieve a leadless pacemaker over time
is important for patients with changing medical conditions which
may necessitate removal of implanted devices. New data presented at
HRS 2016 demonstrated that within the LEADLESS II IDE study and the
LEADLESS Observational Study across Europe, the Nanostim leadless
pacemaker was successfully retrieved in 14 patients up to 3.2 years
post-implantation without any serious adverse events.
“Device retrieval is a desirable feature of implanted leadless
pacemakers because it offers physicians options in the future so
that we can provide optimal care for our patients,” said Dr. Vivek
Reddy, primary investigator of the LEADLESS II study and the
director of electrophysiology from Mount Sinai Hospital in New
York, NY. “We’ve now shown that for patients requiring device
upgrades or new leadless pacing options, late retrievability—even
up to three years—is possible with the Nanostim leadless
pacemaker.”
In two additional clinical presentations, data showed fewer
acute and mid-term complications with the Nanostim leadless
pacemaker compared to traditional transvenous pacemakers and
improved quality of life immediately after implant and over
time.
In a new analysis from LEADLESS II study data and real-world
claims data from the Truven Health MarketScan® database, which
tracks U.S. health care claims and Medicare supplemental insurance
encounters, an international group of researchers found that the
Nanostim leadless pacemaker resulted in fewer complications in both
the first month post-implant as well as in the first two years
post-implant. The data also demonstrated a growing benefit over
time with patients receiving a leadless pacemaker, showing a clear
advantage in combating infections and lead-related adverse
events.
“We are extremely pleased to see these three presentations
provide additional insight into the potential benefits associated
with the Nanostim leadless pacemaker,” said Dr. Mark Carlson, vice
president of global clinical affairs and chief medical officer at
St. Jude Medical. “The Nanostim leadless pacemaker has been
available to patients in Europe since 2013 and we continue to work
with the FDA to bring the Nanostim leadless pacemaker to the U.S.
market to ensure broad patient access to this important
therapy.”
About the Nanostim™ Leadless Pacemaker
A pacemaker is a small implantable device that sends electrical
pulses to the heart to treat bradycardia, a condition in which the
heart rate is too slow. These devices monitor the heart and provide
electrical stimulation when the heart beats too slowly for each
patient's specific physiological requirements. Leadless pacemakers
provide the same type of therapy but do so without the traditional
leads found in conventional pacemakers.
The Nanostim leadless pacemaker operates like a traditional
pacemaker, but is 10 percent the size of a conventional pacemaker.
Implanted via the femoral vein with an 18 F introducer, the
smallest available for a leadless pacemaker, the device offers
patients a minimally-invasive option for pacemaker delivery,
potentially reducing overall complications including device-related
infection of the pocket and lead failure. The Nanostim leadless
pacemaker received CE Mark approval in August 2013. To date, more
than 1,100 Nanostim leadless pacemakers have been implanted
worldwide. The Nanostim leadless pacemaker is undergoing a clinical
study in the U.S. under an FDA-approved investigational device
exemption.
About St. Jude Medical
St. Jude Medical is a leading global medical device manufacturer
and is dedicated to transforming the treatment of some of the
world's most expensive epidemic diseases. The company does this by
developing cost-effective medical technologies that save and
improve lives of patients around the world. Headquartered in St.
Paul, Minn., St. Jude Medical employs approximately 18,000 people
worldwide and has five major areas of focus that include heart
failure, atrial fibrillation, neuromodulation, traditional cardiac
rhythm management and cardiovascular. For more information, please
visit sjm.com or follow us on Twitter @SJM_Media.
Forward-Looking Statements
This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainties. Such forward-looking
statements include the expectations, plans and prospects for the
Company, including potential clinical successes, anticipated
regulatory approvals and future product launches, and projected
revenues, margins, earnings and market shares. The statements made
by the Company are based upon management’s current expectations and
are subject to certain risks and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. These risks and uncertainties include
market conditions and other factors beyond the Company’s control
and the risk factors and other cautionary statements described in
the Company’s filings with the SEC, including those described in
the Risk Factors and Cautionary Statements sections of the
Company’s Annual Report on Form 10-K for the fiscal year ended
January 2, 2016 and Quarterly Report on Form 10-Q for the fiscal
quarter ended April 2, 2016. The Company does not intend to update
these statements and undertakes no duty to any person to provide
any such update under any circumstance.
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version on businesswire.com: http://www.businesswire.com/news/home/20160506005863/en/
St. Jude Medical, Inc.Investor Relations:J.C. Weigelt,
651-756-4347jweigelt@sjm.comorMedia Relations:Gina O'Connell,
651-756-3380Goconnell02@sjm.com
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