Israel-based Transseptal Solutions has received CE mark for a new steerable sheath with a novel approach for transseptal puncture and left atrial navigation.
The TSP Crosser Transseptal Access System is an advanced can transseptal puncture system that can be used in a range of procedures, including LAA appendage closure, mitrla valve repair, mitral valve replacement and EP ablation treatments.
It aggregates sheath, dilator and flexible puncturing needle in a single integrated system for controlled LA access and safety during transseptal catheterization procedures.
A radiopaque loop wire is said to be placed at the distal end of the steerable sheath to help in localizing the fossa ovalis.
The flexible puncturing needle enables deflection and orientation using the steerable sheath, helping to place it in the optimal spot to puncture the fossa ovalis for transseptal access.
In addition, the handle with a rotating collar deflects the steerable sheath tip 180° to each side after crossing into the fossa ovalis.
Earlier this year, the firm completed a10-patient multi-center clinical study in Europe to study the safety and performance of the TSP Crosser transseptal access system.
The company intends to reveal the complete results of the study soon.
Transseptal Solutions CEO Elad Sapir said: "Today, transseptal catheterization is as critical a step for LA interventions as atrial fibrillation ablation, LA appendage closure and mitral valve interventions.
"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.”
Image:Transseptal Solution'sa new steerable sheath for transseptal puncture and left atrial navigation. Photo: courtesy of PRNewsFoto/Transseptal Solutions.