Medtronic (NYSE: MDT) has treated the first U.S. patient in its Global Symplicity Registry DEFINE study, a large international effort to collect real-world data on the company’s Symplicity Spyral renal denervation (RDN) system for patients with uncontrolled hypertension.
The procedure was performed by Dr. Stan Thornton at Thomas Hospital, part of Infirmary Health in Fairhope, Alabama. The U.S. arm of the registry aims to build on existing international data demonstrating the long-term safety and effectiveness of RDN therapy in everyday clinical practice.
“The first patient enrolled in the U.S. expansion of the GSR-DEFINE registry marks a major milestone for the commercial rollout of the Symplicity Spyral RDN system,” said Jason Weidman, senior vice president and president of the Coronary & Renal Denervation business, which is part of the Cardiovascular Portfolio at Medtronic. “We are committed to generating valuable real-world evidence and supporting our mission to make this breakthrough procedure available to the people who need it most.”
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The broader Global Symplicity Registry has already enrolled more than 4,000 patients outside the U.S. According to data presented at EuroPCR 2025, patients in that group saw an average systolic blood pressure reduction of 16.3 mm Hg after three years.
The GSR-DEFINE study aims to enroll 5,000 patients across 251 sites in 55 countries.
Thornton, the principal investigator for the U.S. registry, said the trial could clarify how renal denervation fits into treatment plans for U.S. patients.
“The U.S. GSR-DEFINE study builds on the Global Symplicity Registry with the goal of enhancing our understanding of how renal denervation can improve outcomes for U.S. patients with uncontrolled hypertension in everyday clinical practice,” said Thornton. “We are proud to begin enrolling patients in the trial and treating patients with the Symplicity blood pressure procedure – a promising solution for millions worldwide in need of alternative solutions.”
Renal denervation is a catheter-based procedure that targets overactive nerves in the kidneys that can contribute to elevated blood pressure. While medication and lifestyle changes are the standard of care, many patients remain uncontrolled or become non-adherent over time.
Hypertension affects more than a billion people worldwide and is a leading modifiable risk factor for heart attacks, strokes, and premature death. The Symplicity RDN system is approved in more than 75 countries.
