Technology | February 19, 2008

Septal Occluder Cleared for Use in Very Young Patients

W. L. Gore & Associates (Gore) announced that the FDA granted approval for the use of GORE HELEX Septal Occluder with a modified catheter delivery system indicated for the transcatheter closure of atrial septal defect (ASD), providing a percutaneous ASD closure solution for very young patients.
The GORE HELEX Septal Occluder is a permanently implanted prosthesis that uses ePTFE, a biocompatible material that allows tissue ingrowth, to seal the defect.

Related Content

Le Bonheur Children's Hospital Implants First Abbott Amplatzer Piccolo Occluder
News | Structural Heart Occluders | February 13, 2019
Le Bonheur Children's Hospital cardiologists in Memphis, Tenn., implanted the Amplatzer Piccolo Occluder, the world's...
FDA Approves Abbott's Amplatzer Piccolo Occluder
News | Structural Heart Occluders | January 16, 2019
Abbott announced the U.S. Food and Drug Administration (FDA) approved the Amplatzer Piccolo Occluder to treat patent...
FDA Approves Gore Cardioform Septal Occluder for PFO Closure Prevent Recurrent Ischemic Stroke
Technology | Structural Heart Occluders | April 03, 2018
April 3, 2018 — Following the unprecedented Gore REDUCE Clinical Study conclusion that closure of patent foramen oval
Videos | Structural Heart Occluders | November 08, 2017
John Rhodes, M.D., co-director of the adult congenital heart program, Medical University of South Carolina, is the pr
Videos | Structural Heart Occluders | September 13, 2017
Ziyad Hijazi, M.D., MPH, MSCAI, FACC, director of the cardiac program and chair of the Department of Pediatrics at Si
University of Alabama at Birmingham, Amplatzer PFO Occluder, first implementation
News | Structural Heart Occluders | February 15, 2017
Doctors at the University of Alabama at Birmingham have implemented the first U.S. Food and Drug Administration (FDA)-...
Amplatzer PFO Occluder, St. Jude Medical, Baylor Heart and Vascular Services, Fort Worth, Texas, first patients
News | Structural Heart Occluders | February 01, 2017
Baylor Heart and Vascular Services at Fort Worth in November became the first program in Texas to implant the Amplatzer...
RESPECT trial, Amplatzer PFO Occluder, St. Jude Medical, TCT 2016
News | Structural Heart Occluders | November 02, 2016
St. Jude Medical Inc. announced the long-term data from RESPECT, a landmark trial, during a First Report session at the...
St. Jude Medical, Amplatzer PFO Occluder, FDA approval, U.S. launch
Technology | Structural Heart Occluders | November 02, 2016
St. Jude Medical Inc. announced this week the U.S. Food and Drug Administration (FDA) approval and launch of the...
Overlay Init