Left heart treatment company Transseptal Solutions Ltd revealed on Thursday the receipt of the US FDA's 510(k) clearance for the TSP Crosser Transseptal Access System for the precise and efficient access to the left atrium for transcatheter left atrium procedures.

Based in Israel, the company's TSP Crosser is an advanced transseptal puncture system with a built-in steering mechanism, which is indicated in procedures where access to the left atrium via transseptal technique is desired, including Mitral Valve Repair, Mitral Valve Replacement, Paravalvular leak closure, LAA Closure as well as EP Ablation treatments.

The company has developed the innovative Transseptal Access System with a novel approach of transseptal puncture and left atrial navigation to introduce various cardiovascular catheters into the left heart chambers.

According to the company, the TSP Crosser Transseptal Access System combines a sheath, dilator and a flexible puncturing needle in a single integrated system for controlled LA access and enhanced performance during transseptal catheterization procedures. A radiopaque loop wire is positioned at the distal end of the steerable sheath to aid in the localization of the fossa ovalis. The flexible puncturing needle and the steerable sheath allows pre-puncture deflection and orientation, positioning the needle in the desired puncturing location of the fossa ovalis for transseptal access. The sheath is steerable up to 180° bidirectionally after crossing the fossa ovalis.

In conjunction, the TSP Crosser Transseptal Access System is CE mark approved and is commercial in various territories in Europe and is expected to be available for use in the US, concluded the company.