Medtronic, Inc. (NYSE: MDT), announced today further analysis of six-month follow-up data from the first 1,000 patients enrolled in the Global SYMPLICITY Registry, which continue to demonstrate the safety of the Symplicity(TM) renal denervation system. Presented today during a late-breaking clinical trial session at the 63rd Scientific Sessions of the American College of Cardiology (ACC), the results of this observational, open-label study show that renal denervation with the Symplicity(TM) renal denervation system resulted in significant reductions in both office and 24-hour ambulatory blood pressure compared to baseline, with very low adverse event rates to six months. The Symplicity(TM) renal denervation system is available for investigational use only in the United States.
Of all patients available for six-month follow-up, overall office systolic blood pressure reduction was -11.9 mm Hg and mean 24-hour ABPM systolic blood pressure reduction was -7.9 mm Hg. For the subset of patients with baseline office SBP ≥ 160 mm Hg, and baseline 24 hour mean ABPM SBP ≥ 135 mm Hg that were treated with at least 3 medication classes, similar to those included in all other Symplicity trials, office systolic blood pressure reduction was -20.2 mm Hg.
“The Global SYMPLICITY Registry provides further evidence confirming the well-established safety profile of renal denervation with the Symplicity system,” said Michael Böhm, M.D., Ph.D., chairman, Department of Internal Medicine, University of Saarland, Homburg/Saar, Germany and Global SYMPLICITY Registry co-chair. “Presented on the heels of SYMPLICITY HTN-3, this real-world experience provides a significant contribution to the discussion about the efficacy of renal denervation and offers additional perspective when considering the option of renal denervation in clinical practice for high-risk patients suffering from uncontrolled hypertension who may have limited treatment options.”