Transseptal Solutions Announces First Clinical Use of TSP Crosser in the United States

June 12, 2019—Transseptal Solutions Ltd., an Israel-based developer of the TSP Crosser, which provides transseptal puncture and left atrial navigation in a single device, announced that the first transseptal puncture procedure in the United States was successfully performed by Azeem Latib, MD, in a patient undergoing percutaneous balloon mitral valvuloplasty. The TSP Crosser has FDA clearance in the United States and CE Mark approval in Europe.

Dr. Latib is Medical Director of Structural Heart Interventions and Heart Valve Program at Montefiore-Einstein Center for Heart and Vascular Care in New York, New York. He commented in the company's announcement, “The TSP Crosser is an innovative device that facilitates safe, accurate, and reproducible transseptal puncture. We are honored at Montefiore to be the first United States center to be utilizing this device that will be will benefit both novice and expert structural heart operators."

According to the company, the TSP Crosser transseptal puncture system is designed to provide accurate, quick, and safe access to the left atrium. The device, which features a built-in steering mechanism, 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 TSP Crosser transseptal access system combines a sheath, dilator, and a flexible puncturing needle in a single integrated system for controlled left atrial 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 prepuncture 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, noted the company.