Transseptal Solutions, developer of a new steerable sheath with a novel approach of transseptal puncture and left atrial navigation to treat multiple clinical indications, has received its first CE-Mark for its TSP Crosser Transseptal Access System.

With the increased availability of transcatheter left atrium procedures, there is a growing need to provide surgeons 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, effective in a wide range of procedures: LAA Appendage Closure; Mitral Valve Repair;  Mitral Valve Replacement;  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 safety during transseptal catheterization procedures. A radiopaque loop wire is positioned at the distal end of the steerable sheath to aid in localizing the fossa ovalis. The flexible puncturing needle allows deflection and orientation using the steerable sheath, positioning it in the optimal spot to puncture the fossa ovalis for transseptal access. A handle equipped with a rotating collar deflects the steerable sheath tip 180° to each side after crossing into the fossa ovalis.

"Today, transseptal catheterization is as critical a step for LA interventions as atrial fibrillation ablation, LA appendage closure and mitral valve interventions," said Elad Sapir, Transseptal Solutions CEO. "The availability of suitable tools and techniques is essential to perform the transseptal puncture safely, effectively deliver radiofrequency lesions, deploy LA devices, and anticipate difficult procedural situations in which complications may arise.

"The TSP Crosser Transseptal Access System is designed to provide controlled access and stable catheter positioning in the heart's left atrium via an innovative radiopaque loop wire that allows precise positioning within the right atrium chamber. The wire loop accessory feature is used to find the fossa ovalis easily within the right atrium and provides device stability during an interatrial septum puncture, reducing the risk of known complications due to puncturing of aorta or other structures. Moreover, the deflectability of the puncturing needle and sheath (leading edge technology) means the TSP Crosser Transseptal Access System enables reduced access times and superior precision to puncture the septum and reach targets within the LA anatomy," he added.

Earlier this year, Transseptal Solutions successfully completed a 10-patient multi-center clinical study in Europe to study the safety and performance of the TSP Crosser Transseptal Access System. The company plans to present the complete results of this study.

"We are very pleased with Transseptal Solutions' achievement of a CE Mark for the TSP Crosser Transseptal Access System," said Prof. Francesco Maisano, Head of Cardiovascular Surgery, Zurich University Hospital, and founder of Transseptal Solutions. "This achievement symbolizes a new stage for this field, which had changed very little in the past 50 years. These days it is rising up with new indications and more demanding requirements for accuracy and safety. With the increased safety and the clear indicators providing fossa ovalis visibility and easy localization, combined with the pre-puncture aim of the flexible needle, the TSP Crosser Transseptal Access System created a new environment for the transseptal puncture performance during LA interventions," added Prof. Maisano.

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.