3-in-1 transseptal introducer system receives FDA approval

East End Medical, a Florida-based medical device company focused on interventional cardiology, has gained FDA clearance for its SafeCross Transseptal Radiofrequency (RF) Puncture & Steerable Balloon Introducer System.

The 3-in-1 solution includes an introducer sheath, positioning balloon and RF puncture dilator. It was designed to assist cardiologists performing electrophysiology-related and structural heart disease procedures that require left atrial access.

“With the rapid growth in left atrium procedures, physicians need a single device to precisely gain transseptal access at specific locations on the septum,” Vivek Reddy, MD, director of cardiac arrhythmia services for The Mount Sinai Hospital and Health System in New York City, said in a statement. “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.”

East End Medical has indicated that it plans to offer an “initial limited release” of the SafeCross system before expanding its presence throughout the rest of 2021.

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