Devices FDA Interventional Cardiology

 News Release - October 3, 2007

FDA Approves GORE HELEX Septal Occluder for Treatment of Atrial Septal Defect

Innovative, Less Invasive Treatment Option for Congenital Heart Defect

FLAGSTAFF, Ariz.--(HSMN NewsFeed)--W. L. Gore & Associates (Gore) today announced that the U.S. Food & Drug Administration (FDA) granted approval for the GORE HELEX Septal Occluder with modified catheter delivery system indicated for the transcatheter closure of Atrial Septal Defect (ASD). An ASD is a congenital heart defect that affects thousands of patients every year. The GORE HELEX Septal Occluder is a permanently implanted prosthesis and the first device of its kind to use ePTFE, a biocompatible material that allows tissue ingrowth, to seal the defect. The recently approved catheter-based delivery system allows for easier device deployment via standard femoral venous access, bringing the GORE HELEX Septal Occluder to the forefront of non-surgical ASD repair.

An ASD is an abnormal hole in the wall between the upper chambers of the heart, which allows blood to improperly flow from the left side of the heart to the right, forcing the right side of the heart and lungs to overexert to compensate for the problem. Left untreated, an ASD can cause the heart to enlarge, or weaken, leaving the patient at risk for serious conditions like atrial fibrillation, pulmonary hypertension, heart failure or stroke. The defect is most often treated in pediatric patients.

"In treating such a delicate area of the heart, particularly in small children, interventional cardiologists need to be confident that treatment will be effective for the long term," said Dr. Alexander Javois, The Heart Institute for Children, Advocate Hope Children's Hospital, Oak Lawn, Illinois. "Percutaneous ASD closure is successful in the very young patient using the GORE HELEX Septal Occluder. Its design and conformity allows tissue to incorporate the device easily so that it becomes part of the heart's anatomy, sealing the ASD successfully and improving, even normalizing, the patient's heart function without open heart surgery."

The GORE HELEX Septal Occluder is composed of ePTFE patch material supported by a single nitinol wire frame that bridges and eventually occludes the septal defect to stop the shunting of blood between the atria. Over the course of several weeks to months, cells begin to infiltrate and grow over the ePTFE membrane, resulting in successful closure of the defect.

"Open heart surgery is no longer the only available option to correct an ASD in young children and in patients with complicating health factors. Interventional cardiologists can close the defect permanently through a minimally invasive procedure with a shorter recovery time," said Peter Zeller, PhD, Gore Product Specialist. "The GORE HELEX Septal Occluder has been used in thousands of successful implants worldwide, and we are excited that the device is now available to physicians so that they can treat many more patients in the U.S."

Strong clinical data over the course of several years has demonstrated the efficacy of the GORE HELEX Septal Occluder in treating ASDs. The GORE HELEX Septal Occluder has been used successfully in thousands of implants and has been available in Europe, Latin America and Australia, and under an Investigational Device Exemption (IDE) in the US. The GORE HELEX Device with the original delivery system was previously approved in the United States in August 2006.

ABOUT W. L. GORE & ASSOCIATES

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 25 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair and sutures for use in vascular, cardiac and general surgery. Gore was recently named the tenth best company to work for in America by Fortune.

For more information, visit http://www.goremedical.com/helex.

Products listed may not be available in all markets pending regulatory clearance. GORE and HELEX are trademarks of W. L. Gore & Associates.

Source: W. L. Gore

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