The FDA has approved the Gore Helex Septal Occluder with modified catheter delivery system indicated for the transcatheter closure of atrial septal defect (ASD). 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.
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.
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 US in August 2006.
"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, IL.
"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 normalising, the patient's heart function without open heart surgery."
"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 Dr Peter Zeller, 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 US."
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