Vascular Solutions Announces FDA Clearance of VSI Radial Introducer Sheath

December 8, 2014—Vascular Solutions, Inc. announced that the company’s VSI Radial introducer sheath has received US Food and Drug Administration 510(k) clearance for use in the introduction of guidewires and catheters into a vein or artery. The VSI Radial introducer sheath is specifically designed for patients undergoing transradial catheterization procedures. Vascular Solutions plans to launch the VSI Radial introducer sheath in the United States in January 2015.

According to the company, all 17 models of the VSI Radial introducer sheath contain a hydrophilic-coated introducer sheath and dilator, and the device will be available in three kit options: standard, access, and 035.

The standard kit option is designed for the single-wall micropuncture (modified Seldinger) technique. It consists of nine models that include a sheath, dilator, guidewire, and 21-gauge needle.

The access kit option is designed for the double-wall micropuncture technique (through-and-through puncture or traditional Seldinger technique). It consists of six models that include a sheath, dilator, polymer-coated guidewire, intravenous catheter needle, and syringe.

The 035 kit option is designed for converting a 4-F or 5-F diagnostic procedure into a 6-F interventional procedure. It consists of two models that include a sheath, dilator, and 0.035-inch guidewire.

The company advised that the VSI Radial introducer sheath is manufactured for Vascular Solutions by the China-based LePu Medical Technology (Beijing) Co., Ltd. LePu Medical is the developer of the device, which Vascular Solutions markets under an exclusive United States distribution agreement.