Article preview from IN VIVO - April, 2012
St. Jude Medical hopes an independent analysis of its Optim-insulated Durata leads will address questions from the clinical community based on concerns with its earlier-generation Riata devices.
Article preview from IN VIVO - April, 2012
St. Jude Medical Inc. is seeking a third-party stamp of approval on the safety of its Durata defibrillator leadsin an effort to get out ahead of growing questions in the clinical community based on safety issues with earlier-generation Riata leads. The company will hand over raw data from three ongoing St. Jude-sponsored registries for the currently marketed Durata lead to the Population Health Research Institute, associated with McMaster University in Hamilton, Ontario, under an agreement announced March 25.
Under the arrangement, St. Jude says, the institute will have complete independence in designing and performing analysis of the Durata data, including data already entered into the registries and new data collected at least for the next two years.
The registries are OPTIMUM, SCORE and DF4, which, St. Jude says, in combination contain information from 10,000 leads implanted at 292 sites, including 24,000 patient-years of data. The registries reflect data from the more than five years that the lead, coated with the company’s proprietary Optim insulation material, has been on the market.
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