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"Many centers across the country wanted to be involved in this study. We are quite fortunate to be one of the study sites."
Dr. Joseph Paolillo
Carolinas HealthCare System’s Levine Children’s Hospital is one of 10 sites in the United States selected to be involved in a pivotal trial of a new percutaneous atrial septal defect closure device.
Joseph Paolillo, MD, Sanger Heart & Vascular Institute pediatric cardiologist and director of the pediatric cardiac catheterization laboratory, was asked by W.L. Gore & Associates, Inc. to evaluate the safety and effectiveness of this new device in patients he treats at Levine Children’s Hospital.
Dr. Paolillo was one of the top enrollers in the pivotal phase of this trial, which concluded in June, and continues to enroll a high number of patients in the continued access phase.
“Several of our patients have had challenging atrial defects successfully treated with this new device. By being able to participate in a high profile trial such as this, we now offer transcatheter closure of atrial defects using all available devices in the US. These defects vary in size and shape, and any implanted device must not interfere with other structures in the heart.
"Having this new device in addition to the two already FDA approved devices will hopefully allow us to treat a larger variety of atrial septal defects. Many centers across the country wanted to be involved in this study. We are quite fortunate to be one of the study sites. The Sanger Heart & Vascular Institute Clinical Research Department has been instrumental helping me bring this new technology to Carolinas HealthCare System,” Dr. Paolillo said.
Percutaneous atrial septal defect closure is an alternative to open heart surgery, and only requires an overnight stay. This new implant is made of a five-wire support frame covered with a thin ePTFE, GORE-TEX patch-like material. After the device is implanted, heart lining cells grow over it to seal it in place.
With the pivotal portion of the study completed, Dr. Paolillo is still able to enroll pediatric and adult patients with suitable defects in the study’s continued access phase. The data from the initial group of patients are being analyzed and will be submitted to the FDA for consideration of approval.