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
Company Website:
http://www.sjm.com
ST. PAUL, Minn. & LONDON -- (Business Wire)
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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Contacts:
St. Jude Medical, Inc.
Investor Relations:
J.C. Weigelt,
651-756-4347
jweigelt@sjm.com
or
Media
Relations:
Matt Puplett, +32 2 774 67 22
mpuplett@sjm.com
Source: St. Jude Medical, Inc.
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