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St Jude’s Durata defibrillation lead receives FDA and CE Mark approvals

St Jude Medical : 17 January, 2008  (New Product)
St Jude Medical has announced US Food and Drug Administration (FDA) and European CE Mark approvals of the company’s Durata defibrillation lead.
The Durata, a next generation high voltage lead, features 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 implanting physicians.

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's softer tip and curved coil allow me more control during Implant procedures, as well as more options for lead placement,' said Stephen Stark, MD, clinical professor of medicine, UC Davis Medical Center Electrophysiology Laboratory in Sacramento, California, USA. 'These technological advancements, combined with the thin diameter of the Durata lead, make it easier to Implant and to accommodate additional leads if they are needed.'

The Durata lead is the same size as the company's Riata ST high voltage lead, which at 7 French, are the smallest diameter leads on the market. Small diameter leads may be especially helpful for patients with compromised blood flow or a narrow vasculature, or patients who need CRT-D systems that require three leads to be placed in a single vessel.

Durata is one of several models of implantable cardioverter defibrillator (ICD) leads sold by St Jude Medical. Published data from two large, prospective registries have affirmed the performance and reliability of St Jude Medical lead products. St Jude Medical will continue to offer all prior models of its high voltage leads to physician customers.

All St Jude Medical Durata, Riata ST, and Riata ST Optim ICD 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 and 21cm shock coil spacing, which gives physicians more options when selecting the most appropriate lead for individual patient anatomy.

'We are committed to continuous improvement at St Jude Medical and are constantly evolving our product lines to incorporate new, advanced features, based on physician feedback, to better serve our physician customers and their patients,' said Eric S Fain, president of St Jude Medical's Cardiac Rhythm Management Division. 'By combining next-generation technology with multiple features designed to increase the reliability and durability of our ICD leads, we are confident that the Durata lead will excel in both performance and reliability for patients.'
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