In addition to simple, centrally located Atrial Septal Defects, the non self-centering design is beneficial in the treatment of defects with deficient anterior-superior rim or multiple fenestrations that can be covered by a single occluder.
Yes, the GORE® HELEX® Septal Occluder can be retrieved using the retrieval cord after the lock has been set.
The Occluder is not designed to close Ventricular Septal Defects or Patent Ductus Arteriosus.
Yes, in case of embolization, the GORE® HELEX® Septal Occluder can be recaptured using a snare or other interventional tools.
Yes, the GORE® HELEX® Septal Occluder can be withdrawn into the catheter and repositioned before the lock has been set.
Initially the Nitinol lock secures the left and right disks to each other thereby sealing the defect hole. Later, the porous nature of the ePTFE allows tissue to attach, providing long-term stability.
The device is characterized by a compliant circular shape, a flat profile with no bulky protrusion into the chamber, repositionability, an ePTFE occlusion membrane that permits tissue ingrowth, and a single circumferential Nitinol support frame with low nickel mass and minimal nickel exposure.