Sanford, South Dakota State University team up for clinical trial

By Lisa Gibson

A partnership between Sanford Health and South Dakota State University researchers could result in an FDAapproved, branched stent graft that properly manages blood flow through the aorta to multiple organs. Sanford vascular surgeon Dr. Pat Kelly invented the device and SDSU’s Stephen Gent, associate professor in the Mechanical Engineering Department, is leading a flow modeling data collection phase to complement and expand clinical trials.

The aorta runs from the heart to the legs, branching about halfway down to include four pathways to the intestines, liver and stomach. “Pat has created a system that allows for all that branching to take place,” says Tyler Remund, Sanford Health’s director of commercialization.

Stent grafts are not a new concept in health care, but Kelly’s design uses a cloth frame instead of metal, which is used in traditional stents. Metal allows blood to leak through and come in contact with artery walls, whereas cloth holds the blood safely inside, Remund explains. With a metal frame, in an instance of an aneurysm, the blood pressure continues to expand an artery, or a blood vessel, until it pops. “And then you’ve got a serious problem,” Remund says.

It’s a relatively small subset of patients who experience that particular set of aneurysms, but they have few options for solutions, he says. Kelly’s device could be an important leap in their care.

Sanford is currently conducting clinical trials with the device at five medical centers, but will ramp up in phase two to include 10 to 15 medical centers, about 200 patients and a lot of data, Remund says. The clinical trial will monitor those patients for about a year.

Gent is using computer technology to model the blood flow of the stent, which he hopes will support applications for FDA approval of more clinics participating in the trials, he says. Gent and Remund met in what Gent calls a “chance encounter” for an unrelated project. “We happened to be talking after that meeting about some of the stuff we were doing and he remembered.” Gent had been modeling flows for corn dryers and Remund recalled the research when the stent graft was developed and flow models were needed. “He approached us to see if we’d be interested in modeling the flow mechanics within his device and comparing those with other devices that are on the market,” Gent says.

Gent’s team is working now on setting up a pathway to come up with a protocol to show the models are valid and the data is relevant to moving the product forward. He hopes that will be complete by the end of the year. This project is Gent’s first in the medical realm, he says, adding it’s been fascinating and represents “tremendous opportunities.”

If the FDA gives the green light after the clinical trials have concluded and all data collected, the device can be sold by Medtronic to vascular surgeons around the country, Remund says.

Lisa Gibson EDITOR, PRAIRIE BUSINESS 701.787.6753