Medtronic Announces Data From Global SYMPLICITY Registry

May 21, 2013—Medtronic, Inc. (Minneapolis, MN) announced the first results from the Global SYMPLICITY Registry, which reaffirmed the safety of the renal denervation procedure with the company's Symplicity renal denervation system in a real-world patient population. The data were presented during an oral session on May 23 at EuroPCR 2013 in Paris, France.

According to Medtronic's announcement, among the 617 registry patients with follow-up information available for this first analysis, no major complications or serious adverse events related to delivery of radio frequency (RF) energy to the renal artery were reported. Of these patients, only two experienced access site vascular complications immediately after the procedure. There was a 9% incidence of renal vessel irregularity on angiography due to the application of RF energy to the vessel wall following the procedure; none interfered with brisk renal blood flow, and all are believed to have resolved shortly after the procedure.

The company stated that while the primary goal of the Global SYMPLICITY Registry is to verify procedure safety with the Symplicity system, available data for the secondary efficacy analysis at 6 months showed that renal denervation also has a significant reduction in both office and ambulatory blood pressure compared to baseline. Patients (n = 17) with systolic blood pressure (SBP) of ³180 mm Hg and diastolic blood pressure (DBP) of ³100 mm Hg had an average office blood pressure reduction of -30/-16 mm Hg (SBP, P < .0002; DBP, P < .0008) from baseline at 6 months. Patients (n = 114) with a SBP ³160 mm Hg (or ³150 mm Hg in patients with diabetes) had an average office blood pressure reduction of -18/-9 mm Hg (P < .0001); average blood pressure reduction for these patients who also had ambulatory blood pressure measurement (n = 30) was -11/-4 mm Hg (P < .0001; DBP, P < .256) from baseline.

“These data speak strongly to the safety and efficacy of the renal denervation procedure with the Symplicity system; it is encouraging to see these positive results in a real-world setting,” commented Felix Mahfoud, MD, in the company's press release. Dr. Mahfoud is an interventional cardiologist at the University Hospital Homburg/Saar in Germany. The registry's principal investigator is Michael Boehm, MD, also from the University Hospital Homburg/Saar. Dr. Mahfoud continued, “The significant reductions in blood pressure seen in these patients could substantially reduce cardiovascular risk, as we know that in middle age, even a 2 mm Hg decrease in systolic blood pressure can lead to a decreased risk of death from stroke by 10% and lower risk of death from ischemic heart disease or other vascular cause by 7%.”

The Global SYMPLICITY Registry is a multicenter, prospective, observational registry that will collect comprehensive data evaluating renal denervation and long-term cardiovascular outcomes from hypertension such as stroke, myocardial infarction, heart failure, and cardiovascular death.

Medtronic stated that the registry is the largest patient cohort in renal denervation to date and the first of its kind to evaluate the real-world use of renal denervation in a large and diverse patient population in an uncontrolled setting. The registry will 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 diseases characterized by elevated sympathetic drive, such as diabetes mellitus type 2, heart failure, and chronic kidney disease.

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 company advised.