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• W2062300963 abstract "Existing retrievable filter platforms have limited points of contact with the dynamic IVC wall which are stress points potentially leading to complications of penetration, fracture, and adjacent organ damage. The Convertible Filter is a new concept based on a durable permanent IVC filter design in which the filter is not retrieved but converted into an IVC stent configuration when the risk of VTE has passed. The primary objective is to demonstrate that the rate of successful filter conversion is no lower than the reported IVC filter retrieval success. The secondary objective is to estimate the 6-month major device-related adverse event rate in subjects with a converted filter. This is an IDE multi-center, prospective, single arm, historical controlled study with 12 sites enrolling a combined total of 148 patients. Patients were enrolled for standard indications for retrievable filter placement. When clinically indicated the filter was converted to an open configuration to discontinue filtration. Evaluation of safety and performance in 61 subjects in whom the filter has been implanted, converted and followed for 6 months with imaging has been completed to date. All filter implants were successful. The technical success rate for filter conversion to date is 93% (77/83). The mean time from filter placement to filter conversion for the 83 subjects with conversion attempts is 121 days. No serious conversion-related events have been reported to date. The mean conversion procedure time was 30.9 minutes. In 82% of cases, ancillary devices were used to help convert the filter as allowed per protocol. To date, 61 patients whose filter was converted have completed at least 6 months of follow up with no delayed complications such as migration or penetration of the legs through the wall of the vena cava. Preliminary data suggests the VenaTech Convertible Filter is a safe and effective temporary filter with favorable conversion rates compared to reported IVC filter retrieval rates. Early results show decreased incidence of IVC wall perforation vs current retrievable filter designs and no serious adverse events at 6 months related to filter conversion." @default.
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• W2062300963 date "2015-02-01" @default.
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• W2062300963 title "Muliticenter trial of the VenaTech convertible filter: a novel approach to IVC filtration" @default.
• W2062300963 doi "https://doi.org/10.1016/j.jvir.2014.12.028" @default.
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