3-in-1 System with Steerable Balloon and RF Puncture Enables Successful Left Atrial Procedures

A novel all-in-one radiofrequency (RF) puncture and steerable balloon introducer system for transseptal punctures aims to provide a predictable and safe solution for electrophysiology and structural heart interventions requiring left atrial access.

The SafeCross Transseptal RF Puncture & Steerable Balloon Introducer System from East End Medical (Miramar, FL, USA), which includes a bi-directional steerable introducer sheath with an ultra-visible positioning balloon and RF puncture dilator, is a novel all-in-one system that provides predictable left atrium access to support transseptal interventions. Uniquely designed with an atraumatic contrast-filled positioning balloon on its distal end, the introducer sheath is ultra-visible under echocardiography and X-ray to facilitate precise puncture site selection, while its bi-directional steerability allows for safe maneuvering and perpendicular placement on the septum.

The proprietary RF puncture dilator delivers electrical energy quickly and predictably to puncture the atrial septum. Designed to be compatible with commonly available electrosurgical generators, the needle-less SafeCross System can be easily adopted into clinical practice. The SafeCross Transseptal RF Puncture & Steerable Balloon Introducer System has received U.S. Food and Drug Administration (FDA) clearance and the first commercial devices have been implanted during Left Atrial Appendage Closure (LAAC) and Transcatheter Mitral Valve Edge-to-Edge Repair (TEER) procedures at US hospitals.

"Accessing the left atrium in a safe and precise manner is critical for optimal patient outcomes in left atrial procedures. Depending on the anatomy, achieving safe and precise transseptal access frequently leads to decreased overall left atrial procedure times," stated Dr. Torsten Vahl, Attending Physician at the Structural Heart & Valve Center, who performed the procedure at New York Presbyterian Hospital. "In using SafeCross, I particularly liked how the balloon-tipped sheath allowed me to safely glide across the septum in small and precise adjustments to enable me to position on the exact pre-determined location of the transseptal puncture."

"The highly visible steerable balloon introducer enables precise puncture site targeting and provides the support needed for challenging anatomies," stated Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services, who performed the procedure at The Mount Sinai Hospital. "Additionally, the ability to use it as a steerable guiding sheath makes it a nice potentially all-in-one tool for my workflow. I look forward to incorporating SafeCross into my left-atrial procedures."

"As a structural heart interventional echocardiographer who helps guide these procedures, the steerable balloon sheath and needle-less RF system provides for a very visible, precise, and safe transseptal experience," said Dr. Rebecca Hahn, Director of Interventional Echocardiography at the Columbia Structural Heart & Valve Center, who joined Dr. Vahl in performing the procedure. "The precision and efficiency with which the interventionalist can now perform the transseptal puncture is remarkable and will likely shorten procedure times and improve procedural success."

"With the increasing number of left atrial procedures, it is imperative to have a left atrial access device that helps physicians safely and predictably cross the septum," commented Dr. Martin Leon, Professor of Medicine at Columbia University Medical Center, who also joined Dr. Vahl in performing the procedure. "The SafeCross system represents a novel tool for successful left atrial procedures including left atrial appendage closure (LAAC), transcatheter mitral valve repair (TEER), and atrial fibrillation (AF) ablation procedures among others. I look forward to collecting clinical evidence on the performance of the SafeCross system and to focusing on training initiatives to improve the safety and efficacy of left atrial procedures."

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