Medtronic plc has announced the initiation of the U.S. expansion of the Global SYMPLICITY Registry $(GSR.AU)$ DEFINE clinical trial. This study is focused on documenting the safety and effectiveness of the Symplicity™ Spyral renal denervation $(RDN)$ system in a real-world setting for patients with uncontrolled hypertension. The first U.S. procedure was conducted by Dr. Stan Thornton at Thomas Hospital in Fairhope, Alabama. The GSR-DEFINE trial is an extension of the existing Global SYMPLICITY Registry and aims to enhance understanding of renal denervation's impact on U.S. patients. The trial is a prospective observational study involving 251 sites across 55 countries, with a total of 5,000 patients globally. The Symplicity Spyral RDN system has shown promising results in previous studies, including a three-year decline in office systolic blood pressure of 16.3 mm Hg in evaluated patients outside the U.S. The results of the GSR-DEFINE trial will be documented in the future as the study progresses. The Symplicity RDN system is currently approved for commercial use in over 75 countries.
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