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Radial introducer sheath receives FDA clearance
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Vascular Solutions, Inc. announced that its radial introducer sheath has received FDA clearance for use in the introduction of guidewires and catheters into a vein or artery.
The introducer sheath (VSI Radial) is designed for patients undergoing transradial catheterization procedures, according to a press release. The system contains a hydrophilic-coated introducer sheath and dilator, and will be available in three kit options: one designed for the single-wall micropuncture technique, one designed for the double-wall micropuncture technique and one designed for converting a 4F or 5F diagnostic procedure into a 6F interventional procedure. A total of 17 models of the device will be available across the three kit options, according to the release.
The system was developed by LePu Medical Technology Co. and Vascular Solutions holds an exclusive US distribution agreement for it. Sales in the United States expected to begin during January, according to the release.