St. Jude nets clearance for leads in Japan

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St. Jude Medical has received regulatory and reimbursement approvals for its Durata high-voltage defibrillation lead from the Japanese Ministry of Health, Labour and Welfare.

The St. Paul, Minn.-based company said its Durata lead incorporates a soft silicone tip with a larger surface area and a slightly curved right ventricle shock coil. The Durata lead also incorporates Optim insulation, a hybrid insulation material unique to St. Jude and created for cardiac leads. 

The company said its Durata leads have flatwire technology with silicone backfill to prevent tissue in-growth; dual, redundant cables designed to increase reliability; and single- and dual-coil design with 17-cm and 21-cm shock coil spacing.