Global SYMPLICITY Registry Supports Safety and Efficacy of Medtronic's Renal Denervation System

September 2, 2013—Medtronic, Inc. (Minneapolis, MN) announced that new 6- and 12-month data from the Global SYMPLICITY Registry continue to affirm the strong safety profile of the company's Symplicity renal denervation system in a real-world patient population. Prof. Michael Böhm, MD, who serves as cochair of the Global SYMPLICITY Registry, presented the data at the European Society of Cardiology (ESC) Congress 2013 in Amsterdam, the Netherlands. In May, a first analysis of 617 patients in the study was presented at EuroPCR 2013 in Paris, France.

Medtronic noted that the primary goal of the Global SYMPLICITY Registry is to confirm procedural safety with the Symplicity system. The Symplicity system has received European CE Mark approval and Australian Therapeutic Goods Administration approval. In the United States and Japan, the Symplicity renal denervation system is available for investigational use only.

The Global SYMPLICITY Registry will enroll more than 5,000 patients who compose a real-world, uncontrolled population in a minimum of 200 centers with planned follow-up to 5 years. The registry also will gather data for other diseases characterized by elevated sympathetic drive, such as type 2 diabetes mellitus, heart failure, and chronic kidney disease.

According to the company, in the 1,158 patients analyzed in this registry with follow-up information available for this analysis, major complications or serious adverse events related to delivery of radio frequency (RF) energy to the renal artery were rare, including one procedural dissection (0.09%) and one reintervention at 6 months (0.09%).

Available data for the secondary efficacy analysis showed significant and sustained blood pressure reductions after renal denervation with the Symplicity system at all time points up to 12 months in both in-office and ambulatory blood pressure measurement compared to baseline.

At the ESC meeting, Prof. Böhm reported that patients with systolic blood pressure of ≥ 180 mm Hg at baseline (n = 51) had an average in-office blood pressure reduction of -29/-17 mm Hg from baseline at 6 months (P < .001) and -37/-23 mm Hg from baseline at 12 months (n = 9) (P = .001, systolic; P = .0005, diastolic). Patients with similar characteristics to the Symplicity HTN-2 trial, with a systolic blood pressure of 160 mm Hg (or ≥ 150 mm Hg in patients with diabetes), had an average in-office blood pressure reduction of -19/-8 mm Hg from baseline at 6 months (n = 313) (P < .001) and -22/-11 mm Hg from baseline at 12 months (n = 79) (P < .001). Average reductions in available ambulatory blood pressure measurements were -10/-5 mm Hg from baseline to 6 months (n = 132) (P < .0001).

The Global SYMPLICITY Registry is a multicenter, prospective, observational registry designed to collect comprehensive data evaluating procedural and long-term safety of the Symplicity system, clinical efficacy for both in-office and ambulatory blood pressure measurement, and long-term cardiovascular outcomes from hypertension (such as stroke, myocardial infarction, heart failure, and cardiovascular death). More than 66% of registry patients treated to date fall within current ESC consensus paper recommendations for catheter-based renal denervation, including a systolic blood pressure of ≥ 160 mm Hg (≥ 150 mm Hg, type 2 diabetes) and were taking at least three classes of antihypertensive medications, including diuretic, prior to treatment with renal denervation.

In Medtronic's press release, Prof. Böhm commented, “It is encouraging that preliminary data with this sizeable patient cohort in a real-world setting continue to demonstrate a strong safety profile and significant clinical efficacy for renal denervation with the Symplicity system, similar to what we've been seeing in the randomized, controlled clinical trial, Symplicity HTN-2.”

Prof. Böhm continued, “We are pleased that enrollment and analysis of the registry continues to meet our goal of establishing procedural safety and efficacy of the Symplicity system, which we expect will ultimately help reduce the risk of cardiovascular events associated with treatment-resistant hypertension such as stroke and ischemic heart disease.”