ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced a U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has provided feedback to support the adoption of leadless pacing technology in the U.S. The feedback follows a panel discussion today on leadless pacing technology that included a broad overview of the clinical experience with the St. Jude Medical Nanostim™ leadless pacemaker.
“As the world’s first commercially-available leadless pacemaker with the industry’s least invasive and smallest delivery system, the Nanostim leadless pacemaker was designed to address a number of issues associated with conventional pacemakers and traditional pacemaker leads,” said Dr. Mark Carlson, vice president of global clinical affairs and chief medical officer at St. Jude Medical, who presented to the FDA panel on behalf of the company. “Leadless pacing technology is a critical advancement for patients in need of a single-chamber ventricular pacemaker, and we are optimistic that today’s discussion is an important step toward offering patients leadless pacing technology in the United States.”
After a presentation on the clinical experience with the Nanostim leadless pacemaker, the FDA’s Circulatory System Devices Panel provided recommendations that were consistent with many of St. Jude Medical’s proposed recommendations related to post approval study design and training for physicians who seek to offer the Nanostim leadless pacemaker to their patients. The panel also provided valuable insight around patient selection and post approval study methodology.
The Nanostim leadless pacemaker operates like a traditional pacemaker, but is 10 percent the size of a conventional pacemaker and is designed to reduce or eliminate complications associated with leads, chest incisions and surgical pockets. The Nanostim leadless pacemaker received CE Mark approval in October 2013. To date, more than 1,000 Nanostim leadless pacemakers have been implanted worldwide.
Recent data from the LEADLESS II IDE study published in The New England Journal of Medicine confirmed the benefits of the Nanostim leadless pacemaker. The LEADLESS II study also highlighted the retrievability of the Nanostim leadless pacemaker, which allows the Nanostim leadless pacemaker to be repositioned throughout the implant procedure and retrieved even after more than a year implanted in patients when necessary.
“We’re highly appreciative of the FDA’s proactive effort to gain more insight and understanding around leadless pacing technology, and for the opportunity to participate in the dialogue that will help ensure that leadless technology is adopted with patient safety in mind and with successful clinical outcomes as a top priority,” Dr. Carlson said.
The Nanostim leadless pacemaker is not approved in the U.S. and limited by federal law to investigational use.
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 has five major areas of focus that
include heart failure, atrial fibrillation, neuromodulation, traditional
cardiac rhythm management, and cardiovascular diseases. 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 October 3, 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.
