FDA Classifies St. Jude Medical Field Action for 447 of the Company's Optisure High Voltage Leads as a Class 1 Advisory in th...
January 22 2016 - 4:30PM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced that a previously communicated voluntary
global field safety action related to the company’s Optisure™ Dual
Coil Defibrillation Leads has now been classified as a Class 1
Advisory by the U.S. Food and Drug Administration. The Class 1
Advisory relates to a limited and well-defined group of 447
Optisure leads, 278 of which were distributed in the U.S., which
may have been damaged during a manufacturing step. The company has
received no reports of lead malfunction or patient injury related
to this issue and all physicians with patients impacted by this
advisory have been notified.
Optisure dual coil defibrillation leads are used in conjunction
with implantable cardioverter defibrillators (ICDs), which monitor
the heartbeat of patients suffering from heart rhythm disorders. An
ICD’s leads deliver electric current to the heart to help restore
the heart to its normal rhythm when needed.
On November 3, 2015, St. Jude Medical began the global process
of notifying physicians following patients who have been implanted
with the 447 Optisure dual coil leads subject to this advisory. An
investigation revealed a variation in the process to remove excess
medical adhesive used in the assembly of the superior vena cava
(SVC) shock coil in a limited and well-defined group of Optisure
leads could result in cuts to the insulation of the lead. Depending
on device programming and the depth of the inadvertent cut to the
insulation, compromise of lead insulation can potentially lead to
an electrical malfunction wherein the defibrillator cannot deliver
appropriate high voltage therapy.
A St. Jude Medical internal investigation found the probability
that a lead was damaged as a result of the manufacturing variation
to an extent that it could result in the inability to deliver
appropriate high voltage therapy is very low and that any
associated risks can be prevented with device reprogramming. The
patients’ leads can also be monitored from home using the
Merlin.net™ remote care system. The company has not received any
reports of compromised performance of the impacted Optisure leads.
St. Jude Medical is in the process of providing an updated advisory
notice to physicians to further ensure physicians are aware of
recommendations for managing their patients who may have been
implanted with the impacted leads.
The advisory notification involves the worldwide distribution of
447 Optisure dual coil defibrillation leads manufactured and
distributed by St. Jude Medical. The advisory relates to units
within the following models: LDA220, LDA220Q, LDA230Q, and
LDP220Q.
The vast majority of patients implanted with the Optisure leads
compromised by the advisory have devices equipped with the St. Jude
Medical DynamicTx™ feature that provides additional protection to
help ensure delivery of appropriate high voltage therapy even in
the case of a compromised lead. For these patients, physicians are
advised to enroll patients in the Merlin.net patient care network,
ensure the DynamicTx feature is programmed “on” and then monitor
patients as per normal follow-up protocols.
Physicians following the nine (9) patients in the U.S. with
compromised leads not connected to a device with the DynamicTx
feature have been advised to enroll these patients in the
Merlin.net patient care network and, where appropriate, consider
turning off the SVC coil. If a dual coil shocking configuration is
desired, physicians should consider performing a high voltage test
when clinically appropriate to determine whether the lead has been
compromised. As of this letter all physicians following the nine
patients have been contacted and provided information about this
event.
Patient safety is St. Jude Medical’s highest priority, and the
company will continue to work closely with customers and global
regulatory agencies to ensure effective communication to our
physician partners. The company has alerted all physician customers
impacted by the advisory by letter and all leads subject to this
advisory have been accounted for and none remain in any field
distribution. The U.S. Food and Drug Administration and other
regulatory bodies have been notified. For more information,
patients or their physicians can visit www.sjm.com/optisureadvisory
or call the St. Jude Medical customer service team 24 hours a day
at (800) 328-9634.
About St. Jude MedicalSt. 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 StatementsThis 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160122005944/en/
St. Jude Medical, Inc.J.C. Weigelt, 651-756-4347Investor
Relationsjweigelt@sjm.comorJustin Paquette, 651-756-6293Public
Relationsjpaquette@sjm.com
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