FDA Clears Transseptal Solutions Access System

FDA has cleared a Transseptal Solutions 510(k) for the TSP Crosser Transseptal Access System, a transseptal puncture system with a built-in steering mechanism, indicated for use in procedures where access to the left atrium via transseptal technique is desired (e.g., mitral valve repair or replacement, paravalvular leak closure). The device comprises a sheath, dilator and a flexible puncturing needle in a single integrated system for controlled left atrial access during transseptal catheterization procedures, according to the company. “A radiopaque loop wire is positioned at the distal end of the steerable sheath to aid in the localization of the fossa ovalis,” it says. “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.”