St Jude Medical 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, 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 shock coil. The lead design is identical to Durata distal to the superior vena cava 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.
“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, multicentre studies,” says Raymond H M Schaerf, a thoracic and cardiac surgeon at Providence Saint Joseph Medical Center, in Burbank, California, USA.
The Optisure lead has been approved by the US Food and Drug Administration (FDA), European CE mark, Health Canada, Therapeutic Goods Administration (TGA) in Australia and Japanese Ministry of Health, Labour and Welfare (MHLW).