W. L. Gore & Associates reported the first patient enrolled in the Gore Septal Occluder Clinical Study evaluating the new Gore Septal Occluder that is used to repair a heart defect. The patient was successfully treated at Duke University Medical Center in North Carolina by John Rhodes, MD, chief of the Congenital Heart Center.
Gore is headquartered in Newark, Del., with its medical business based in Flagstaff, Ariz.
“The first procedure using the Gore Septal Occluder was successful and the patient is doing well, having left the hospital the next day,” said Rhodes. “The Gore device has an exceptional design that makes it easy to deploy, and the innovative ePTFE material conforms to the heart for optimal patient outcomes. It is critical for physicians to help complete studies like this in an effort to get new and novel technologies into the hands of doctors to aid patient needs.”
The Gore Septal Occluder received CE Mark approval in June 2011. Globally, more than 1,500 devices have been implanted successfully. The US prospective, multicenter, single-arm, clinical study will compare the GORE Septal Occluder to outcomes from previous Gore Helex Septal Occluder clinical studies. The Gore Study will collect patient data six months post-procedure and will continue to monitor patients for three years from 50 patients at 11 investigational sites.
Leveraging more than 13 years of clinical experience with septal occluders, the GORE Septal Occluder is a next generation device that successfully integrates innovative material and design to yield a treatment option whose discs are intended to conform to the anatomy of the individual patient. The Gore device is comprised of a five-wire support frame covered with a thin ePTFE, patch-like material.