St. Jude Medical Announces Japanese Approval of the Durata Defibrillation Lead

St. Jude Medical, Inc. announced regulatory approval, in addition to reimbursement approval, from the Japanese Ministry of Health, Labour and Welfare (MHLW), for the Durata™ defibrillation lead, the company's next-generation high-voltage lead. The Durata lead incorporates a soft silicone tip with a larger surface area and a slightly curved right ventricle (RV) shock coil intended to enhance ease of use and handling for physicians implanting an ICD system in patients at risk for dangerously fast heart rhythms. The Durata lead also incorporates Optim® insulation, a hybrid insulation material unique to St. Jude Medical and created specifically for cardiac leads. Optim insulation 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 Durata lead is the same size as the company's Riata® ST Optim™ lead which, at 7 French, is the smallest diameter high-voltage lead on the market. Small diameter leads may be especially helpful for patients with compromised blood flow, a narrow vasculature, or patients who need CRT-D systems that require three leads to be placed in a single vessel. Eric S. Fain, MD, president of the St. Jude Medical Cardiac Rhythm Management Division, said “This new lead combines next-generation technology with features designed to increase reliability and long-term durability and thereby reduce risks.” St. Jude Medical® Durata leads have additional exclusive features including: • Flatwire technology with complete silicone backfill designed to prevent tissue in-growth. • Dual, redundant cables designed to increase reliability, so that if one cable is damaged another will provide backup. • Single- and dual-coil design with 17 cm and 21 cm shock coil spacing, which gives physicians more options when selecting the most appropriate lead for individual patient anatomy. “The expansion of our high-voltage product offerings in Japan with these state-of-the-art leads will help us meet the needs our physician customers around the world,” said Paul Bond, chairman of St. Jude Medical Japan Co., Ltd.