Image: SafeCross System crossing the atrial septum using the RF Puncture Dilator (Photo courtesy of East End Medical)
A new all-in-one radiofrequency (RF) puncture and steerable balloon introducer system for transseptal punctures aims to provide a predictable and safe solution for electrophysiological and structural cardiac procedures requiring left atrial access.
The SafeCross Transseptal RF Puncture & Steerable Balloon Introducer System from East End Medical (Miramar, FL, USA), which includes a bidirectional steerable introducer sheath with a high-visibility positioning balloon and an RF puncture dilator, is a new all-in-one system that provides predictable access to the left atrium to support transseptal procedures. Uniquely designed with an atraumatic contrast-filled positioning balloon at its distal end, the introducer sheath is highly visible under echocardiography and x-rays to facilitate precise puncture site selection, while its bi-directional direction allows maneuverability safe 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-free SafeCross system can be easily adopted into clinical practice. The SafeCross Transseptal RF Puncture & Steerable Balloon Introducer System has received US Food and Drug Administration (FDA) clearance and the first commercial devices have been implanted upon closure of the left atrial appendage ( LAAC) and transcatheter mitral valve edge-to-edge repair (TEER) procedures in US hospitals.
“Accessing the left atrium safely and accurately is critical to achieving optimal patient outcomes in left atrial procedures. Depending on the anatomy, obtaining safe and accurate transseptal access often leads to an overall decrease in left atrial procedure times,” said Dr. Torsten Vahl, Attending Physician at Structural Heart & Valve Center, who performed the procedure. at New York Presbyterian Hospital. “While using SafeCross, I particularly liked how the balloon-tipped sheath allowed me to slide securely over the septum with small and precise adjustments to allow me to position myself at the exact predetermined location of transseptal puncture.
“The highly visible, steerable balloon introducer allows for precise targeting of the puncture site and provides the support needed for challenging anatomy,” said Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services, who performed the procedure at the Mount Sinai Hospital. “Plus, the ability to use it as a steerable guide sheath makes it a nice potentially all-in-one tool for my workflow. I look forward to integrating SafeCross into my left atrial procedures.”
“As a cardiac structural interventional echocardiograph that helps guide these procedures, the steerable balloon sheath and needle-free RF system allow for a highly visible, accurate, and safe transseptal experience,” said Dr. Rebecca Hahn, Director of the interventional echocardiography at Columbia Structural Heart & Valve Center, who joined Dr. Vahl in performing the procedure. “The precision and efficiency with which the operator can now perform the transseptal puncture is remarkable and will likely reduce 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 cross the septum in a safe and predictable manner,” 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 new tool for successful left atrial procedures, including left atrial appendage closure (LAAC), transcatheter mitral valve repair (TEER), and fibrillation ablation procedures. atrial (AF), among others. I look forward to gathering clinical evidence on the performance of the SafeCross system and focusing on training initiatives to improve the safety and effectiveness of left atrial procedures. »