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The TSP Crosser Transseptal Access System is intended to both puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left side of the heart.

The TSP Crosser System is intended to be used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left heart chambers. The main components of the TSP Crosser System are: - . Steerable introducer sheath with handle and radiopaque wire loop that is compatible with catheters up to 8F - . Dilator that is compatible with guidewires up to a maximum diameter of 0.035" - Transseptal needle with Stylet ● The System is provided sterile (EO) and is intended for single use only. The device is designed to provide controlled transseptal access in the cardiac left atrial anatomy. The TSP catheter introducer sheath is an elongated shaft with a central lumen capable of incorporating the needle and stylet assembly, the dilator, as well as allow passage and orientation of operational catheters up to 8F. The introducer incorporates a steerable tip that can be deflected bidirectionally up to 180° with a curvature radius of 22mm. The steerable introducer handle includes a rotating knob that maintains the rotational and longitudinal positioning of the sheath and deflects the sheath's tip 180° on each side. There is a nitinol loop wire positioned at the distal end of the introducer that is visible under fluoroscopy and provides a visual aid to the user when positioning the needle on the fossa ovalis. The introducer contains a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with a three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The dilator has an outer diameter of 8F and inner diameter of 0.035" and includes a central lumen that facilitates the transseptal needle/stylet in a similar fashion to conventional dilators. The transseptal needle assembly consists of a luminal stainless-steel needle and solid stainlesssteel stylet. The needle is used to puncture the interatrial septum during the catheterization procedure and houses a central lumen that accommodates the stylet.