An investigational device invented at Sanford Health in Sioux Falls, South Dakota, that helps high-risk vascular disease patients has been granted a Breakthrough Device designation by the Food and Drug Administration (FDA).
The standard of care is complex open surgery, which is associated with a high rate of complications and mortality, and 40% of patients are not considered candidates for open surgical repair.
Kelly’s concept has the potential to treat more of those people utilizing his minimally invasive approach. Under a physician-sponsored investigational device exemption (PS-IDE), he has treated more than 150 patients at Sanford Health over the past nine years who otherwise had no other options.
“This helps move the device through the regulatory pathway,” said Kelly. “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 non-anatomical design allows broad applicability of our patient population.”