Optisure Defibrillation Lead Provides System Enhacement
The Optisure defibrillation lead is an addition to St. Jude Medical'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 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 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.
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).
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