FDA Clears Transseptal Solutions' Transseptal Access System

October 11, 2018—Transseptal Solutions Ltd. announced FDA 510(k) clearance for the TSP Crosser transseptal access system, which is desgined to provide precise and efficient access to the left atrium. The TSP Crosser will soon be available for use in the United States. The device is also CE Mark approved and is commercially available in various territories in Europe.

The Israel-based company's system provides a novel approach of transseptal puncture and left atrial navigation to introduce various cardiovascular catheters into the left heart chambers.

The TSP Crosser is indicated for use in procedures where access to the left atrium via transseptal technique is desired, such as mitral valve repair, mitral valve replacement, paravalvular leak closure, left atrial appendage closure, and electrophysiology ablation treatments. The system features a built-in steering mechanism and combines a sheath, dilator, and flexible puncturing needle in a single integrated system for controlled left atrial access and enhanced performance during transseptal catheterization procedures, stated the company.