NETANYA, Israel, Oct. 11, 2018 /PRNewswire/ -- Transseptal Solutions Ltd., developer of an 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, announced today that the company has received FDA 510(k) clearance for the TSP Crosser™ Transseptal Access System.
A new approach to the growing need for precise and efficient access to the left atrium
With the increased availability of transcatheter left atrium procedures, there is a growing need to provide physicians with tools that allow accurate, quick and safe access to the left atrium. TSP Crosser™ is an advanced 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, such as:
Mitral Valve Repair
Mitral Valve Replacement
Paravalvular leak closure
LAA Closure
EP Ablation Treatments
TSP Crosser: Transseptal puncture and left atrial navigation in a single device
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.
"Transseptal catheterization is a critical step for structural heart and electrophysiology LA interventions," said Elad Sapir, Transseptal Solutions CEO. "The availability of advanced tools and techniques is essential to perform accurate transseptal puncture as part of challenging LA 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 localization 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 LA anatomy," he added.
