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St. Jude Medical Announces Global Launch of Optisure Defibrillation Lead

  St. Jude Medical Announces Global Launch of Optisure Defibrillation Lead

The Optisure lead expands on the St. Jude Medical high-voltage product
portfolio, providing an additional system enhancement for addressing lead
complications and improving system reliability

Business Wire

ST. PAUL, Minn. -- March 24, 2014

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today
announced the global launch of the Optisure™ Defibrillation Lead. This new
lead is an addition to the company’s Optim™ lead family, joining the proven
Durata™ Defibrillation Lead, which is supported by more than six years of
implant experience and the most robust post-market surveillance monitoring in
the industry.

Based on the established Durata lead design, the Optisure lead features
additional Optim insulation at the proximal end of the lead, including under
the superior vena cava (SVC) shock coil. The lead design is identical to
Durata distal to the SVC shock coil. Optim insulation is a hybrid insulation
material unique to St. Jude Medical and created specifically for cardiac
leads. It blends the biostability and flexibility of high-performance silicone
rubber with the strength, tear resistance and abrasion resistance of
polyurethane to provide increased durability, along with the flexibility and
handling characteristics that facilitate device implantation. With both 7 and
8 French diameter leads, the St. Jude Medical high-voltage portfolio now
provides physicians more treatment options to tailor therapy to individualized
patient needs.

“The Optisure lead has a thicker layer of Optim insulation that adds
additional abrasion resistance to a lead that has already demonstrated
excellent safety and reliability, backed by clinical evidence from St. Jude
Medical as well as large, independent, multi-center studies,” said Dr. Raymond
H. M. Schaerf, a thoracic and cardiac surgeon at Providence Saint Joseph
Medical Center, in Burbank, Calif.

The Optisure defibrillation lead is compatible with all of the company’s
implantable cardioverter defibrillators (ICDs) and cardiac resynchronization
therapy defibrillators (CRT-Ds), including the company’s next-generation
Ellipse™ and SJM Assura™ portfolio of ICDs and CRT-Ds. The Ellipse and SJM
Assura family of devices feature the DynamicTx™ Over-Current Detection
Algorithm, which automatically adjusts shocking configurations within the
device to ensure the delivery of high-voltage therapy if an electrical short
in one portion of the system were to occur. In addition, the next-generation
Ellipse and SJM Assura portfolio of implantable defibrillators feature low
friction coating on the device, which has been demonstrated in testing to
significantly reduce the friction between the device and leads. Physicians
using the St. Jude Medical high-voltage system, now including the Optisure
lead, have access to the most advanced portfolio of products to address
commonly known causes of lead failure.

“Today’s announcement reinforces our commitment to continuous innovation
across our entire cardiac rhythm management portfolio with a particular focus
on system reliability,” said Eric S. Fain, group president at St. Jude
Medical. “The Optisure lead builds on the proven track record of our Durata
lead and Optim insulation, which is supported by a large body of evidence that
will continue to grow through our active post-market registries.”

The St. Jude Medical high-voltage portfolio is reinforced by the excellent
performance of the Durata defibrillation lead. With approximately 11,000 leads
actively monitored in prospective active registries and more than 27,000
patient years of data, the Durata lead continues to demonstrate strong safety
and reliability.

The Optisure lead has been approved by the U.S. Food and Drug Administration
(FDA), European CE Mark, Health Canada, Therapeutic Goods Administration (TGA)
in Australia and Japanese Ministry of Health, Labor and Welfare (MHLW).

A lead is a thin insulated wire that is placed through the vein as part of a
pacemaker or ICD implantation procedure. The tip of the lead is attached to
the heart tissue, and the other end connects to the pacemaker or ICD. A lead
carries electrical impulses from the pacemaker or ICD to the heart and
transmits information from the heart back to the implanted device.

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 December 28, 2013. The Company
does not intend to update these statements and undertakes no duty to any
person to provide any such update under any circumstance.

Contact:

St. Jude Medical, Inc.
Investor Relations
J.C. Weigelt, 651-756-4347
jweigelt@sjm.com
or
Media Relations
Amy Jo Meyer, 651-756-3029
ameyer@sjm.com
 
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