LEADLESS II Trial Results Published in The New England Journal of Medicine Confirm the Positive Benefits of the Nanostim Lead...
August 30 2015 - 4:11AM
Business Wire
Data from the LEADLESS II study also highlighted the St. Jude
Medical Nanostim leadless pacemaker’s retrievability, projected
longevity and the promising future of leadless pacing
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced primary results from the LEADLESS II study
that confirm the positive benefits of the Nanostim™ leadless
pacemaker for patients in need of a single-chamber ventricular
pacemaker. The study also demonstrated the Nanostim leadless
pacemaker’s longer-term retrievability and the device’s significant
projected battery longevity.
The LEADLESS II investigational device exemption (IDE) study is
the largest published study to date to evaluate leadless pacing
technology, having enrolled 526 patients at 56 centers across the
United States, Canada and Australia. Earlier today, results from
the study were published online in The New England Journal of
Medicine and presented during a Hotline session at the ESC Congress
2015.
“We are excited to share the results of LEADLESS II, which
continues to grow the body of evidence supporting the safety and
efficacy of the Nanostim leadless pacemaker,” said Dr. Vivek Reddy,
the study’s principal investigator and director of
electrophysiology serves at The Mount Sinai Hospital in New York.
“The LEADLESS II study results are advancing our understanding of
leadless pacing technology and highlighting a number of benefits
for physicians seeking a minimally invasive, leadless option for
patients in need of permanent, single chamber pacing therapy.”
After six months, data from LEADLESS II shows the trial met both
endpoints for primary effectiveness (appropriate pacing and
sensing) and safety (freedom from serious adverse device effects).
In addition, data from LEADLESS II also demonstrated:
- Nanostim Leadless Pacemaker’s
Retrievability. Retreivability is a core benefit of the
Nanostim leadless pacemaker. Over the duration of the study,
LEADLESS II demonstrated that retrieval of the implanted Nanostim
leadless pacemaker was successful in 100 percent of patients
requiring retrieval without any associated complications.
- Projected Longevity of the Nanostim
Leadless Pacemaker. Based on data from LEADLESS II, Nanostim
leadless pacemaker’s battery could be projected to last an average
of 15 years, and possibly projected as high as 21 years depending
on pacing needs. The longevity of the Nanostim device has been
estimated to be 9.8 years at 100 percent pacing.
“Leadless pacing is a new frontier for modern medicine, and a
potential solution for physicians who want to retain the
reliability of conventional pacing options but offer their patients
a less invasive procedure,” said Mark Carlson, M.D., chief medical
officer for St. Jude Medical. “The Nanostim leadless pacemaker
allows for a procedure without the need for a surgical pocket or
the leads required by traditional pacemakers. Combined with prior
data from the LEADLESS trial, the results of LEADLESS II
demonstrate the Nanostim leadless pacemaker should be considered as
a clinical alternative by physicians who want to provide patients a
leadless pacing option that offers long-term longevity and device
retrievability.”
The Nanostim leadless pacemaker originally received CE Mark in
October 2013. Unlike conventional pacemakers that require more
invasive surgery, the Nanostim leadless pacemaker is designed to be
implanted minimally invasively via the femoral vein. The system is
implanted with the smallest available leadless technology delivery
system, which includes the delivery system catheter and an 18 F
introducer. The Nanostim leadless pacemaker eliminates the surgical
pocket and leads, which represent the most vulnerable component of
traditional pacing systems. The Nanostim device is entirely
self-contained and at approximately 1.5 inches long and under 6mm
in diameter is less than 10 percent the size of a conventional
pacemaker.
Within the LEADLESS II study, a total of 22 serious adverse
device effects were observed over six months, including cardiac
perforation, device dislodgement, and elevated pacing capture
thresholds at rates of 1.3 percent, 1.7 percent, and 1.3 percent,
respectively, which is consistent with traditional pacemakers.
Dr. Reddy is the Chair of the Steering Committee for the
LEADLESS II trial, and has received consulting fees from St Jude
Medical.
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer
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 has four major clinical focus areas that include
cardiac rhythm management, atrial fibrillation, cardiovascular and
neuromodulation. 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 3, 2015 and Quarterly Report on Form 10-Q for the fiscal
quarter ended July 4, 2015. 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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St. Jude Medical, Inc.Investor Relations:J.C. Weigelt,
651-756-4347jweigelt@sjm.comorMedia Relations:Matt Puplett, +32 2
774 67 22mpuplett@sjm.com
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