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.