Six-Month Analysis of Global SYMPLICITY Registry Supports Safety of Medtronic's Renal Denervation System

March 30, 2014—Medtronic, Inc. (Minneapolis, MN) announced to the presentation of an analysis of 6-month follow-up data from the first 1,000 patients enrolled in the Global SYMPLICITY Registry. The data were presented during a late-breaking clinical trial session at ACC.14, the 63rd scientific sessions of the American College of Cardiology (ACC) in Washington, DC.

According to Medtronic, the Global SYMPLICITY Registry continues to demonstrate the safety of the company’s Symplicity renal denervation system. The results of this observational, open-label study show that renal denervation with the Symplicity system resulted in significant reductions in both office and 24-hour ambulatory blood pressure compared to baseline, with very low adverse event rates to 6 months. The Symplicity renal denervation system is available for investigational use only in the United States, advised the company.

Michael Böhm, chairman of the Department of Internal Medicine at the University of Saarland in Homburg/Saar, Germany, serves as cochair of the Global SYMPLICITY Registry.

In Medtronic’s press release, Dr. Böhm commented, “The Global SYMPLICITY Registry provides further evidence confirming the well-established safety profile of renal denervation with the Symplicity system. 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.” Medtronic announced the presentation of the full results of SYMPLICITY HTN-3 trial on March 29 at the ACC.14 meeting. Unlike the Global Registry, SYMPLICITY HTN-3 included a sham arm and showed no significant between-group difference in blood pressure at 6 months.

According to Medtronic, the Global SYMPLICITY Registry is evaluating uncontrolled hypertension patients and the safety of renal denervation procedure with the Symplicity renal denervation system in a real-world setting. The primary goal of the registry is to confirm procedural safety with the Symplicity system and monitor the office and 24-hour ambulatory blood pressure, as per standard of care at the enrolling centers.

Of the 1,000 patients enrolled at the time of the analysis, 6-month safety data were available for 913 patients. The data showed renal denervation with the Symplicity system was associated with adverse events in < 1% of patients, with no cases of renal artery stenosis resulting from the procedure.

Medtronic reported that of all patients available for 6-month follow-up, overall office systolic blood pressure reduction was 11.9 mm Hg (n = 751), and 24-hour ambulatory systolic blood pressure reduction was 7.9 mm Hg (n = 404). For patients with office blood pressure ≥ 160 mm Hg and ambulatory blood pressure ≥ 135 mm Hg at baseline receiving three or more antihypertensive medication classes had a blood pressure reduction of 20.2 mm Hg at 6 months (n = 244).

The Global SYMPLICITY Registry will seek to enroll more than 5,000 patients in a minimum of 200 centers with planned follow-up to 5 years. The registry will also gather data for other comorbid diseases often associated with hypertension and by elevated sympathetic drive, such as diabetes mellitus type 2, heart failure, and chronic kidney disease, advised Medtronic.