Gore receives positive reports related to GORE HELEX Septal Occluder

W. L. GORE & ASSOCIATESAug 23 2011

Last sentence of release following the boilerplate should read: GORE®, GORE-TEX®, HELEX®, and designs are trademarks of W. L. Gore & Associates. (sted GORE^®, VIATORR^®, and designs are trademarks of W. L. Gore & Associates.)

“Material matters, and we are pleased that the data regarding our signature ePTFE material in the unique GORE HELEX Septal Occluder proves it.”

The corrected release reads:

GORE RECEIVES ZERO REPORTS OF EROSION ASSOCIATED WITH GORE® HELEX® SEPTAL OCCLUDER

Worldwide Data Provides Confidence in Device as Permanent Heart Implant

W. L. Gore & Associates (Gore) today reported that it has received zero accounts of erosion of the aortic root or the free wall of the atrium associated with the worldwide use of the GORE® HELEX® Septal Occluder. The positive data comes from more than a decade of clinical experience using the Gore Device. Encouraging news for the thousands of patients treated with the GORE HELEX Septal Occluder to close the genetic condition of atrial septal defect (ASD), an abnormal hole in the wall between the heart's upper chambers. Leading cardiologists with experience using the Gore Device credit the expanded polytetrafluorethylene (ePTFE) material, a biocompatible material that allows tissue ingrowth to seal the defect.

"I have now used the GORE HELEX Device in more than 250 patients with excellent results. The complication rate is low and the closure rate is high," said Ziyad M. Hijazi, MD, Course Director, PICS; Director, Rush Center for Congenital and Structural Heart Disease, Professor of Pediatrics and Internal Medicine, and Section Chief Pediatric Cardiology at Rush University Medical Center in Chicago. "When treating an ASD, if the Gore Device is appropriate, I will use it right away as the material is very soft and conforms to the shape of the hole. The GORE-TEX material is key."

"The GORE HELEX Septal Occluder is a device made mostly of GORE-TEX patch and minimal metal frame. It poses a low risk of thrombus formation on the disc, atrial arrhythmia complications from the device, and no reported cases of injury to the heart wall resulting in perforation, a potentially life-threatening complication," stated John F. Rhodes, MD, Associate Professor in Pediatrics and Medicine at Duke University, Chief of the Children's Heart Center, and Director of the Pediatric and Adult Congenital Cardiac Catheterization Laboratory in Durham, North Carolina.

According to Thomas Forbes, MD, Director, Cardiac Catheterization Laboratory at Children's Hospital of Michigan in Detroit; and Assistant Professor of Pediatrics at Wayne State University in Detroit, "There is no question that the GORE HELEX material is more conformable to the atria. The material's mid and long term closure performance has been proven. I have treated hundreds of patients with the Gore Device and they have done extremely well. Overall, I am very happy with the experience."

The GORE HELEX Septal Occluder is a permanently implanted prosthesis and catheter delivery system, with deployment via standard femoral venous access. First used in Europe in 1999 and approved by the FDA in 2006, the occluder is composed of ePTFE patch material supported by a single nitinol wire frame. Over the course of several weeks to months following implantation of the device, cells begin to infiltrate and grow over the ePTFE membrane, aiding in the successful closure of the defect.

"Gore is committed to long term performance and quality in ensuring positive patient outcomes," said Stuart Broyles, PhD, Associate with the Gore Medical Division Stroke Business. "Material matters, and we are pleased that the data regarding our signature ePTFE material in the unique GORE HELEX Septal Occluder proves it."