SPYRAL HTN-ON MED study shows significant, consistent, long-term blood pressure lowering effect at two years

Core Insights - Medtronic announced long-term data from the SPYRAL HTN-ON MED clinical trial, demonstrating significant reductions in blood pressure for patients undergoing radiofrequency renal denervation with the Symplicity™ Spyral system compared to sham patients at two years [1][2] - The company is expanding its clinical research efforts with the SPYRAL GEMINI pilot study to investigate multi-organ denervation and the GSR-DEFINE trial to include sites in the United States [3][5] Group 1: Clinical Trial Results - The SPYRAL HTN-ON MED trial showed a treatment difference in 24-hour ambulatory systolic blood pressure (ABPM) of -5.7 mmHg (RDN group: -12.1 mmHg vs. sham group: -7.0 mmHg, p=0.039) and in office-based systolic blood pressure (OSBP) of -8.7 mmHg (RDN group: -17.4 mmHg vs. sham group: -9.0 mmHg, p=0.0034) at two years [2] - No confirmed renal artery stenosis greater than 70% was reported in the Spyral group at the two-year mark, indicating long-term safety [2] Group 2: Future Clinical Programs - The SPYRAL GEMINI pilot study will explore the safety and efficacy of multi-organ denervation in patients with uncontrolled hypertension, both on and off medications [3][4] - The GSR-DEFINE trial is an extension of the Global SYMPLICITY Registry, aiming to enroll up to an additional 2,000 patients globally across 251 sites in 55 countries [5] Group 3: Company Positioning and Commitment - Medtronic emphasizes its unique position to explore blood pressure lowering through multi-organ denervation, supported by its intellectual property and the design of the Symplicity Spyral catheter [4] - The company is committed to evidence generation and innovation in interventional hypertension treatments, reinforcing its leadership in the field [6]