Transseptal Solutions has received FDA 510(k) clearance for its TSP Crosser transseptal access system. A press release reports that the system has a novel approach of transseptal puncture and left atrial navigation to introduce various cardiovascular catheters into the left heart chambers, adding that the system has a built-in steering mechanism.
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 electrophysiological ablation treatments.
According to the press release, the TSP Crosser combines a sheath, dilator and a flexible puncturing needle in a single integrated system for controlled left atrium access and enhanced performance during transseptal catheterisation procedures. A radiopaque loop wire is positioned at the distal end of the steerable sheath to aid in the localisation 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-degree bidirectionally after crossing the fossa ovalis.
Francesco Maisano (Zurich University Hospital, Zurich, Switzerland), founder of Transseptal Solutions, says: “Transseptal Solutions FDA clearance announcement is timely. There is a growing global demand for trans-septal catheter intervention for patients with structural heart disease. The TSP Crosser is an innovative integrated solution addressing the unmet need for precise and controlled transseptal puncture.”
Elad Sapir, Transseptal Solutions CEO, comments: “Transseptal catheterisation is a critical step for structural heart and electrophysiology left atrium interventions. The availability of advanced tools and techniques is essential to perform accurate transseptal puncture as part of challenging left atrium interventions. The TSP Crosser is designed to provide controlled access and stable catheter positioning into the heart’s left atrium. An innovative radiopaque loop wire aids in the localisation of the fossa ovalis within the right atrium and provides device stability during an interatrial septum puncture. Moreover, the flexible puncturing needle allows deflection and orientation using the steerable sheath to provide adjustable positioning for puncturing the fossa ovalis and ensuring the TSP Crosser successfully reaches its target location within the left atrium anatomy.”