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The AMPLATZER™ TorqVue™ LP Catheter is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.

The AMPLATZER TorqVue Low Profile Delivery Catheter (TVLPC) is an extension of the AMPLATZER TorqVue Low Profile Delivery System (TVLP) product line. The TVLPC is identical to the TVLP with the exception of a delivery wire, which is omitted on the TVLPC catheter only product. The TorqVue LP Catheter includes a catheter, loader, Tuohy-Borst hemostasis valve, and a self-sealing hemostasis valve. The TorqVue LP Catheter is intended for use with AMPLATZER devices packaged with a delivery wire. Figure 1 illustrates the delivery system and identifies the following essential components: Catheter – Single-lumen catheter that is used to deliver the device after it has . been positioned by the physician. The body of the catheter is radiopaque to increase visibility when using fluoroscopy. The distal end of the catheter is curved approximately 90°. Tuohy-Borst hemostasis valve – An adapter designed to control back-bleeding ● from the Delivery Catheter. . Loader - catheter short tube with luer fittings that aids in placing the desired devices into the Delivery Catheter. ● Self-sealing hemostasis valve - An adapter designed to control back-bleeding from the Delivery Catheter. The self-sealing valve provides additional sealing capabilities for use with delivery wires of smaller diameters.