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
cmpany'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
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
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.
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.
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