IDE Study Will Evaluate Physician-Developed TAAA Stent Graft
February 19, 2015—Sanford Health of Sioux Falls, South Dakota, announced that it has commenced enrollment in the Sanford Health Visceral Manifold Study for the repair of thoracoabdominal aortic aneurysms (TAAA) using an investigational device and procedure developed by Sanford Health’s Patrick Kelly, MD. The study will be performed under a physician-sponsored Investigational Device Exemption from the US Food and Drug Administration.
According to Sanford Health, the study will evaluate the safety profile of the stent graft system. Patients must meet requirements related to the location, size, history of growth, and risk of rupture of their aneurysm. Enrollees must also be older than 18 and have a life expectancy greater than 1 year.
Dr. Kelly and colleagues described the TAAA stent graft system in the Journal of Vascular Surgery (2014;60:1177–1184).
In the Sanford Health announcement, Dr. Kelly commented, “This less-invasive method is important for patients who, for various reasons, are not candidates for more invasive methods of treatment and are limited in care options. Patients with TAAA who enroll in this trial may be able to help advance the science behind treating aortic disorders.”
The clinical study is part of Sanford’s Advanced Aortic Program, which provides diagnosis, second opinions, and noninvasive treatments for peripheral vascular disease. Dr. Kelly is medical director of Sanford Vascular Services, Sanford Wound Clinic, and the Sanford Advanced Aortic Program in the Sioux Falls region. He is a board-certified and fellowship-trained vascular and general surgeon. Additionally, Dr. Kelly holds numerous patents and patent applications for medical devices and has served as a principal investigator for several clinical trials.