Craig Straley

Clinical & Regulatory Director at Fogarty Institute of Innovation

With more than 25 years of experience conducting clinical research, Craig has forged strong relationships with co-workers, health-care providers, patients, and regulators. It has been a rewarding way to combine his engineering education—he holds a BSE and ME in Biomedical Engineering from Duke University—with his strong interest in medicine to help drive medical device innovation.

Craig has worked at both large companies and early-stage startups, most recently at Medtronic, following its acquisition of Twelve, Inc. As vice president of clinical affairs at Twelve, Craig developed and executed the early clinical studies for the Transcatheter Mitral Valve Replacement program. Earlier, as VP of clinical affairs at Ardian, Craig led the early stage clinical studies for a first-of-its-kind therapy of renal denervation, culminating in Ardian’s acquisition by Medtronic.

One of Craig’s proudest professional achievements is Ardian’s groundbreaking European randomized study of renal denervation to treat hypertension. He is delighted not only with beating enrollment projections and the trial’s ultimate success, but also with the team he worked with, including the physicians, research nurses, as well as the patients who courageously agreed to participate.

At Fogarty Innovation, Craig continues to embrace Dr. Fogarty’s philosophy of a “patient-first” focus, emphasizing to the companies-in-residence that developing robust clinical evidence will drive the ability to benefit the most patients.


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