Tele: 561.316.3330
Breaking Medical Device News

Saturday, October 16, 2021
HomeFDAEast End Medical Announces FDA Clearance Of Its SafeCross™ Transseptal RF Puncture...

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

East End Medical, is a private medical device company committed to improving catheter-based cardiac procedures. Today the company announced it received U.S. Food and Drug Administration (FDA) clearance for the company’s SafeCrossTransseptal 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.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

Arlington Scientific Broadens Product Portfolio and Further Expands its Product Offering Through the acquisition of Non-Mammalian Blocking Buffers

Arlington Scientific, Inc. (ASI) is pleased to announce that it has acquired the non-mammalian blocking buffer product line from Clark McDermith, former owner of...

Laborie Medical Technologies Acquires Pelvalon

Laborie was represented by Piper Sandler (financial advisor) and Simpson Thacher & Bartlett LLP (legal advisor). Pelvalon was represented by J.P. Morgan Securities LLC (financial advisor) and Dorsey & Whitney LLP (legal advisor).

Herculite Products, Inc. Promotes Two Employees to New Roles

Paul Flaherty Chief Strategy Officer and Marco Angelone is being promoted to the role of Chief Financial Officer.

Prof. Joseph Kvedar Added to the Sweetch Advisory Board Member

Prof. Josdeph Kvedar is the current chair of the board at the American Telemedicine Association (ATA), formerly VP of Connected Health at Mass-Gen Brigham, co-chair of the American Medical Association (AMA) Digital Medicine Payment Advisory Group, and author of The Internet of Healthy Things and The New Mobile Age.

Sid Bala Named President of HealthChampion

Sid Bala is the former president and chief executive officer of alligatortek, a custom software applications company that was acquired by HealthChampion in 2020 where he led them for 27 years after he founded the business

Cochlear Announces FDA Approval and Clearance of first-of-its-kind Remote Care Capabilities for Nucleus and Baha Systems

The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution is the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.

By using this website you agree to accept Medical Device News Magazine Privacy Policy