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Classified in: Health
Subject: FDA

East End Medical Announces FDA Clearance Of Its SafeCrosstm Transseptal RF Puncture And Steerable Balloon Introducer System


MIAMI, July 13, 2021 /PRNewswire/ -- East End Medical, a private medical device company committed to improving catheter-based cardiac procedures, today announced it received U.S. Food and Drug Administration (FDA) clearance for the company's SafeCrosstm Transseptal Radiofrequency (RF) Puncture & Steerable Balloon Introducer System. The 3-in-1 system, which includes a steerable introducer sheath with an ultra-visible positioning balloon and radiofrequency (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 Dr. Martin Leon, Professor of Medicine at Columbia University Medical Center (CUMC). "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 maneuvering 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 Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services for The Mount Sinai Hospital and Health System. "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 U.S. 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.

The SafeCross Transseptal RF Puncture & Steerable Balloon Introducer System will be on display at booth 1361 at the Heart Rhythm Society (HRS) meeting in Boston, MA on July 28-31, 2021. 

About East End Medical
East End Medical was founded to improve catheter-based cardiac procedures. The company's first product, the SafeCross Transseptal RF Puncture & Steerable Balloon Introducer System, provides physicians with a predictable and safe solution for crossing the atrial septum using a single device.
For more information, please visit safecrossdevice.com.

SOURCE East End Medical


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