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Press Release

Transseptal Solutions Announces CE Mark for a New Steerable Sheath with a Novel Approach for Transseptal Puncture and Left Atrial Navigation

U.S. Food and Drug Administration
Posted on: 30 Oct 16

TEL AVIV, Israel, October 28, 2016 /PRNewswire/ --

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

A new approach to the growing need for safe access to the left atrium 

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

TSP Crosser: Transseptal puncture and left atrial navigation in a single device 

The TSP CrosserTM 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 CrosserTM 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 CrosserTM Transseptal Access System enables reduced access times and superior precision to puncture the septum and reach targets within the LA anatomy," he added.

Clinical study completed and system endorsed by opinion leaders  

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 CrosserTM 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 CrosserTM 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 CrosserTM Transseptal Access System created a new environment for the transseptal puncture performance during LA interventions," 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.

For more information, please contact:

Elad Sapir, elad@tspmedical.com

For more information:
www.prnewswire.com/news-releases/transseptal-solutions-announces-ce-mark-for-a-new-steerable-sheath-with-a-novel-approach-for-transseptal-puncture-and-left-atrial-navigation-599057271.html

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 30/10/2016

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