St. Jude Medical Inc. has launched its Optisure Defibrillation Lead, an addition to the company's Optim lead family, on the global market.
Optisure joins the Durata Defibrillation Lead, which is supported by more than six years of implant experience and robust post-market surveillance monitoring.
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 company claims.
“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 St. Jude’s implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), including its 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.
“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 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 Optisure lead has been approved by the U.S. Food and Drug Administration, European CE Mark, Health Canada, Therapeutic Goods Administration in Australia and Japanese Ministry of Health, Labor and Welfare.
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.
Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.
