Medtronic Treats First U.S. Patient in Global SYMPLICITY Registry DEFINE Study
Large, international registry designed to expand real-world data for Symplicity blood pressure procedure for uncontrolled hypertension
Large, international registry designed to expand real-world data for Symplicity blood pressure procedure for uncontrolled hypertension
Medtronic News
Medtronic announced the first U.S. patient treated in the Global SYMPLICITY Registry (GSR) DEFINE clinical trial, documenting the safety and effectiveness of the Symplicity™ Spyral renal denervation (RDN) system in a real-world setting. The first procedure was performed by Dr. Stan Thornton of Thomas Hospital, an affiliate of Infirmary Health in Fairhope, Alabama.
“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.”
The GSR-DEFINE trial is an extension of the Global SYMPLICITY Registry, the largest study documenting the long-term safety and effectiveness of the Symplicity Spyral RDN system in a real-world setting in patients with uncontrolled hypertension. At the recent EuroPCR conference in Paris, Medtronic reported that GSR showed three-year declines in office systolic blood pressure of 16.3 mm Hg in 1,450 patients evaluated from outside the U.S. 1 With over 4,000 patients already enrolled outside of the U.S., GSR-DEFINE is a prospective, all-comer observational study in 251 sites across 55 countries including 5,000 patients globally.
“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 Stan Thornton, MD, Cardiologist at Cardiology Associates at Thomas Hospital and Principal Investigator for the U.S. GSR DEFINE registry study. “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.”
Hypertension, or high blood pressure, impacts more than 1 billion adults worldwide, and is the leading modifiable cause of heart attack, stroke, and death.2 Despite available treatment with medications and lifestyle changes, blood pressure remains uncontrolled for many patients. Nearly 80% of adults with hypertension do not have it under control3 and half of hypertension patients become non-adherent to medication within one year.2-4
The Symplicity RDN system is approved for commercial use in over 75 countries around the world.
1 Mahfoud F, et al. EuroPCR 2025. Results include Symplicity Spyral and Flex catheters
2 WHO. Hypertension fact sheet. September 13, 2019. Available at: https://www.who.int/news-room/fact-sheets/detail/hypertension. Accessed February 15, 2022.
3 Mahfoud F, Kandzari DE, Kario K, et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomized, sham-controlled trial. The Lancet. 2022; 399:1401-1410.
4 Bhatt, D. et al, Long-term outcomes after catheter-based renal artery denervation for resistant hypertension: final follow-up of the randomised SYMPLICITY HTN-3 Trial. The Lancet. September 18, 2022. DOI: https://doi.org/10.1016/S0140-6736(opens new window)(22)01787-1.
