The company has obtained the US Food and Drug Administration, Health Canada, Australian Therapeutic Goods Administration, and Japanese Ministry of Health, Labor and Welfare approvals for the Optisure defibrillation lead.

The Optisure ICD lead is a new option in the Optim family of ICD leads, built on the Durata lead design, for physicians who prefer a larger lead diameter.

The device has an 8F lead body with additional Optim insulation, a chemical co-polymer that offers superior handling and durability, at the proximal end of the lead and under the superior vena cava (SVC) shock coil.

Lead design of Optisure is identical to Durata distal to the SVC shock coil.

The device 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.

It expands on the St. Jude Medical high-voltage product portfolio, providing an additional system enhancement for addressing lead complications and improving system reliability.

According to St. Jude Medical, physicians using its 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.

St. Jude Medical group president noted that the Optisure lead builds on the proven track record of the company’s 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.

Image: St. Jude Medical’s new global headquarters in Minnesota. Photo: Courtesy of St. Jude Medical Inc.