March 20, 2012—Gore & Associates (Flagstaff, AZ) reported the beginning of enrollment in Australia for the company’s Global Registry for Endovascular Aortic Treatment (GREAT).
The registry is part of Gore’s postmarket surveillance effort to monitor patient outcomes and device performance in treatments with Gore’s TAG thoracic endoprosthesis, the Excluder abdominal aortic aneurysm (AAA) endoprosthesis, and the Excluder AAA endoprosthesis with the C3 delivery system.
The first Australian patients in the GREAT registry were successfully treated for thoracic and abdominal aneurysms by vascular surgeons Steven Dubenec, MD, and Michael Stephen, MD. Patients are enrolled in GREAT once a procedure using a Gore endovascular device has been completed. The registry has enrolled 274 patients in 15 sites globally since August 2010, stated the company.
According to the company, GREAT monitors outcomes during patient treatment and posttreatment visits for up to 10 years, providing longer-term follow-up than has been collected in past prospective registries. Active tracking of long-term device performance and associated patient outcomes will provide additional details regarding global trends in device usage. The company stated that this information will offer insights into clinical needs that may advance future aortic endovascular therapies.
“Australia and New Zealand have had an international presence as leaders in the development and advancement of aortic endovascular procedures since their inception,” commented Dr. Dubenec, who serves as National Principal Investigator for GREAT in Australia and New Zealand. “I believe GREAT will be a pivotal registry that may advance aortic endovascular therapies in the future.”
He added, “Our regional participation in this registry demonstrates the commitment of Australian and New Zealand vascular interventionists to ongoing advancements in patient care in this field. Our patients can be assured that they are continuing to be offered the optimal technologically advanced, proven, and safe therapies for the treatment of aortic disease.”
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