FDA approval for SafeCross transseptal RF system

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SafeCross

East End Medical has announced it has received US Food and Drug Administration (FDA) clearance for the company’s SafeCross transseptal radiofrequency (RF) puncture & steerable balloon introducer system. The three-in-one system, which includes a steerable introducer sheath with an ultra-visible positioning balloon and RF puncture dilator, aims to provide a predictable and safe solution for electrophysiology and structural heart interventions requiring left atrial access.

“Transseptal crossing is required for a growing number of catheter-based procedures, including left atrial appendage closure, transcatheter mitral valve repair, and atrial fibrillation ablation. Current septal puncture devices require careful technique, controlled force, and can be challenging in certain anatomies or subsequent procedures,” commented Martin Leon, professor of medicine at Columbia University Medical Center (CUMC, New York, USA). “The SafeCross system can simplify left atrial access and improve safety during these procedures. I am excited for the meaningful impact this innovation will have for patients.”

The SafeCross system’s contrast-filled positioning balloon is ultra-visible under echocardiography and X-ray to facilitate precise puncture site selection, while the bi-directional steerable introducer sheath allows for safe manoeuvring 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 SafeCross system can be easily adopted into clinical practice.

“With the rapid growth in left atrium procedures, physicians need a single device to precisely gain transseptal access at specific locations on the septum,” said Vivek Reddy, director of Cardiac Arrhythmia Services for The Mount Sinai Hospital and Health System, New York, USA. “The SafeCross System, with the unique steerable balloon and RF puncture, was designed to provide physicians the control required to precisely select sites and puncture the septum in an efficient, safe, and reproducible manner.”

“We look forward to bringing this technology to the US market with an initial limited release followed by expanded commercial efforts by the end of 2021,” stated Anthony Medigo, chief commercial officer of East End Medical.


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