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Devices Interventional Cardiology FDA

 News Release - October 11, 2018

Transseptal Solutions Announces FDA Clearance of Its Novel Transseptal Access System for Transseptal Puncture and Left Atrial Navigation

NETANYA, Israel, Oct. 11, 2018 -- (Healthcare Sales & Marketing Network) -- 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.

Clinical experience and system endorsed by opinion leaders

TSP Crosser™ Transseptal Access System is CE mark approved and is commercial in various territories in Europe. With the recent FDA clearance, the TSP Crosser System will soon be available for use in the United States.

"Transseptal Solutions FDA clearance announcement is timely. There is a growing global demand for trans-septal catheter intervention for patients with structural heart disease," said Prof. Francesco Maisano, Head of Cardiovascular Surgery, Zurich University Hospital, and founder of Transseptal Solutions.

"The TSP Crosser is an innovative integrated solution addressing the unmet need for precise and controlled transseptal puncture," added Prof. Maisano.

About Transseptal Solutions

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.

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Source: Transseptal Solutions

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