East End Medical Announces FDA Clearance of its SafeCross ™ Transseptal RF Puncture System and Steerable Balloon Introducer

East End Medical Announces FDA Clearance of its SafeCross ™ Transseptal RF Puncture System and Steerable Balloon Introducer

MIAMI, July 13, 2021 / PRNewswire / – East End Medical, a privately held medical device company engaged in improving cardiac catheter procedures, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for the company’s SafeCross.â„¢ Radiofrequency (RF) transseptal puncture and steerable balloon introduction 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 procedures structural cardiacs requiring left atrial access.

“Transeptal crossing is required for an increasing number of catheter procedures, including left atrial appendage closure, catheter mitral valve repair and atrial fibrillation ablation. Current septal puncture devices require careful technique, controlled force and can be difficult in some 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 delighted with the significant impact this innovation will have on 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 two-way swivel introducer sheath allows for safe maneuvers 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 of left atrium procedures, physicians need a single device to accurately achieve transseptal access to specific locations on the septum,” said Dr. Vivek Reddy, director of cardiac arrhythmia services for Mount Sinai Hospital and Health System. “The SafeCross System, with the unique steerable balloon and RF puncture, was designed to provide physicians with the control required to accurately select sites and perforate the septum efficiently, safely and reproducibly.”

“We look forward to bringing this technology to the US market with a limited first release followed by increased commercial efforts by the end of 2021,” said Anthony Medigo, Commercial Director of East End Medical.

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

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

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SOURCE Eastern Medical Center

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