St. Jude Medical Announces Global Launch of Optisure Defibrillation Lead

March 28, 2014 — St. Jude Medical Inc. announced the global launch of the Optisure defibrillation lead. This new lead is an addition to the company’s Optim lead family, joining the Durata defibrillation lead.

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 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 Raymond H. M. Schaerf, M.D., 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. 

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.

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