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• W1976025710 abstract "To evaluate the safety and effectiveness of the retrievable Option™ inferior vena cava (IVC) filter when used as both a permanent and temporary filter in patients at increased risk for pulmonary embolism (PE). This was a multicenter, single-arm clinical trial conducted in subjects at risk for PE for whom anticoagulation was either contraindicated or had failed. One hundred adult subjects, mean age 59 years, underwent implantation of the Option™ IVC Filter. Subjects were followed up to 180 days post-implantation. Retrieved subjects (n=39) had their filter removed within that interval; Permanent subjects (n=61) did not. The primary objective was to demonstrate that the one-sided lower limit of the 95% confidence interval for the observed Clinical Success rate was ≥ 80%, where Clinical Success was defined as placement technical success without subsequent PE, significant filter migration or embolization, symptomatic caval thrombosis or other complications requiring filter removal/intervention. At entry, 34 subjects had venous thromboembolic disease (VTE) and a contraindication to anticoagulants, 35 were prophylactic with multiple risk factors but no VTE, 15 were prophylactic with VTE, 9 had VTE and bleeding complications while anticoagulated, and 7 had VTE and had failed anticoagulation. Clinical Success was achieved in 88% (88/100) subjects. Retrieval success was achieved in 92.3% of Retrieved subjects (36/39); the mean implantation time for retrieved filters was 67 days. No filter embolization, caval perforation, or fracture occurred. There were 5 reports of suspected PE, 2 of symptomatic caval thrombosis, and 4 of filter tilt > 15 degrees. One case of recurrent PE and one case of caval thrombosis were judged to be definitely related to the study device. All deaths (15) and cases of deep vein thrombosis (14) were adjudicated to be unrelated to the device or procedure. In this study, pre-defined clinical success was achieved in 88% of cases and retrieval was successful in 92% of subjects in whom it was attempted. The safety profile of the Option IVC filter was consistent with other IVC filters." @default.
• W1976025710 created "2016-06-24" @default.
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• W1976025710 date "2009-02-01" @default.
• W1976025710 modified "2023-09-26" @default.
• W1976025710 title "Abstract No. 29: The Safety and Effectiveness of the Retrievable Option™ Inferior Vena Cava Filter: A Prospective, Multicenter U.S. Clinical Study in Patients at Permanent or Temporary Risk for Pulmonary Embolism" @default.
• W1976025710 doi "https://doi.org/10.1016/j.jvir.2008.12.032" @default.
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