TAAA Stent Graft System Developed at Sanford Health Receives FDA Breakthrough Device Designation

October 19, 2021—Sanford Health announced that the investigational aortic stent graft system for the treatment of thoracoabdominal aortic aneurysms (TAAAs) designed by vascular surgeon Patrick Kelly, MD, has been granted Breakthrough Device designation by the FDA.

"This helps move the device through the regulatory pathway," commented Dr. Kelly in the Sanford Health announcement. "It opens the door for more patients to have an option for repair, even the potential for patients with aortic dissections, failed prior repairs, and anatomies that were previously thought to be untreatable. The nonanatomical design allows broad applicability of our patient population."

Sanford Health is an integrated health system headquartered in the Fargo, North Dakota, and Sioux Falls, South Dakota, regions.

According to Sanford Health, the Mobile Limb stent graft system is designed to be an an off-the-shelf endovascular solution for complex TAAA repair; its mobile limb technology is not restricted by anatomy and conforms well to tortuosity, potentially enabling use in the setting of failed previous repairs. The system requires no custom build time and no complicated wires or procedural steps.

Sanford Health advised that device has been evaluated under an FDA physician-sponsored investigational device exemption (PS-IDE) to treat more than 150 patients at Sanford Health during the past 9 years. There was no other treatment option for these patients. Among these patients, 73 (49%) had undergone previous repair. Overall, the device had been implanted in more than 200 patients in seven independent PS-IDE studies, noted Sanford.

The platform was covered in detail by Dr. Kelly in the March 2021 edition of Endovascular Today.