St Jude Medical has announced regulatory approval, in addition to reimbursement approval, from the Japanese Ministry of Health, Labour and Welfare, for the Durata defibrillation lead.
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The company said that the Durata lead incorporates a soft silicone tip with a larger surface area and a slightly curved right ventricle shock coil intended to enhance ease of use and handling for physicians implanting an implantable cardioverter defibrillator 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, the company added. It is reported that 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.
Eric Fain, president of the St Jude Medical cardiac rhythm management division, said: “The Durata lead represents St Jude Medical’s commitment to continuous innovation and improvement, incorporating new features based on physician feedback to better serve our physician customers and their patients. This new lead combines next-generation technology with features designed to increase reliability and long-term durability and thereby reduce risks.”
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