Transseptal Solutions, developer of an innovative Transseptal Access System with a novel approach of transseptal puncture and left atrial navigation, announced the completion of the first TSP Crosser transseptal puncture procedure in the US.

Transseptal Solutions Ltd. - TSP Crosser Transseptal Access System

Image: TSP Crosser transseptal access system. Photo: courtesy of PRNewswire / Transseptal Solutions Ltd.

The procedure was successfully performed by Dr. Latib, the New Medical Director of Structural Heart Interventions and Heart Valve Program at Montefiore-Einstein Center for Heart and Vascular Care in patient undergoing Percutaneous Balloon Mitral Valvuloplasty (PBMV) treatment.

“The TSP crosser is an innovative device that facilitates safe, accurate and reproducible transseptal puncture. We are honored at Montefiore to be the 1st US center to be utilizing this device that will be will benefit both novice and expert structural heart operators,” said Dr. Latib.

“It is a major milestone for Transseptal Solutions to launch our activity in the US, we are very excited for the completion of the first clinical case with the outstanding Montefiore’s structural heart interventions team,” added Elad Sapir, Transseptal Solutions CEO.

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

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. The TSP Crosser™ has an FDA clearance and CE mark.

“Transseptal catheterization is a critical step for structural heart and electrophysiology LA interventions,” said Elad Sapir, Transseptal Solutions CEO. “The TSP Crosser™ provides a stable catheter positioning, with reproducible and controlled transseptal access, essential for performing accurate transseptal puncture as part of challenging LA interventions.

Transseptal Solutions was founded in 2013 and is based in Israel. Transseptal Solutions brings to the market a new steerable sheath with a novel approach of transseptal puncture and left atrial navigation. By addressing significant unmet market needs, Transseptal Solutions seeks to improve the LA access procedure and generate a novel approach to serve the expanding indications of left heart treatment.

Source: Company Press Release