SafeCross Transseptal Balloon Gets First Commercial Use

SafeCross System Crossing the Atrial Septum Using the RF Puncture Dilator

East End Medical has announced the first commercial use of its SafeCross transseptal radiofrequency (RF) puncture and steerable balloon introducer system. The system is designed to provide a predictable and safe solution for performing electrophysiological and structural cardiac procedures requiring left atrial access, the company said in a press release.

The first commercial devices were implanted during the Left Atrial Appendage Closure (LAAC) and Transcatheter Mitral Valve Edge-to-Edge Repair (TEER) procedures at New York Presbyterian Hospital – Columbia, performed by Martin Leon (Columbia University Medical Center, New York, USA). ), Torsten Vahl and Rebecca Hahn.

Atrial fibrillation (AF) and ventricular tachycardia (VT) ablation procedures using the SafeCross system were also performed at Mount Sinai Hospital (New York, USA) by Vivek Reddy and Srinivas Dukkipati.

“Accessing the left atrium in a safe and precise manner is essential for optimal patient outcomes in left atrial procedures. Depending on the anatomy, obtaining safe and accurate transseptal access often leads to an overall reduction in left atrial procedure times,” Vahl said. “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 pre-determined location of the septum. transseptal puncture.”

“The highly visible, steerable balloon introducer allows for precise targeting of the puncture site and provides the support needed for challenging anatomy,” Reddy said. “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.

The system consists of a bidirectional steerable introducer sheath and radiofrequency puncture dilator, and is designed with an atraumatic contrast-filled positioning balloon on 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 for safe maneuvering and perpendicular placement over the septum. The exclusive RF Puncture Dilator delivers electrical energy quickly and predictably to puncture the atrial septum.

“As a structural cardiac 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,” says Hahn. “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 Leon, “The SafeCross System represents a new tool for successful left atrial procedures including LAAC, transcatheter mitral valve repair (TEER) and AF ablation procedures, among others I look forward to gathering clinical evidence on the performance of the SafeCross System and to focus on training initiatives to improve the safety and effectiveness of left atrial procedures.

“We are delighted to have successfully completed the first commercial cases of the SafeCross System, a significant milestone for our company,” said Anthony Medigo, Chief Commercial Officer of East End Medical. “The SafeCross System brings several benefits to physicians performing left atrial procedures and we look forward to bringing this important technology to more hospitals in the US market later this year.”