East End Medical’s SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System Cleared by FDA

July 13, 2021—East End Medical announced that it received FDA clearance for the company’s SafeCross transseptal radiofrequency (RF) puncture and steerable balloon introducer system. The company will introduce the SafeCross system at the Heart Rhythm 2021, the annual meeting of the Heart Rhythm Society on July 28-31, 2021, in Boston, Massachusetts.

“We look forward to bringing this technology to the United States 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.

According to the company, the three-in-one system includes a steerable introducer sheath with an ultravisible positioning balloon and RF puncture dilator to provide a predictable and safe solution for electrophysiology and structural heart interventions requiring left atrial access. The device is designed to be compatible with commonly available electrosurgical generators and easily adopted into clinical practice.

“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,” commented Martin Leon, MD, in the company’s press release. “Current septal puncture devices require careful technique, controlled force, and can be challenging in certain anatomies or subsequent procedures. 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.”

Vivek Reddy, MD, added, “With the rapid growth in left atrium procedures, physicians need a single device to precisely gain transseptal access at specific locations on the septum. 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.”