Medtronic’s Symplicity RDN System Assessed in 3-Year GSR DEFINE Data

May 23, 2023—Medtronic announced the findings from two studies supporting radiofrequency (RF) renal denervation (RDN) with the company’s Symplicity system for the treatment of patients with uncontrolled hypertension. Global SYMPLICITY Registry DEFINE (GSR DEFINE) is a prospective, all-comer, observational study conducted at 247 sites in 55 countries outside of the United States evaluating RF RDN with Symplicity. Additionally, a new analysis demonstrated that the Symplicity RDN procedure is cost-effective in a European setting.

The studies’ findings were delivered as moderated poster presentations at the EuroPCR conference held May 16-19 in Paris, France.

GSR DEFINE was launched in May 2021. To date, 3,332 patients have been enrolled (2,231 with the single-electrode Symplicity catheter and 1,101 with the Symplicity Spyral multielectrode RDN catheter) out of 5,000.

According to the company, the current analysis assessed blood pressure (BP) and cardiovascular events at 3 years after the RDN procedure. The findings demonstrated that Medtronic’s Symplicity RF RDN system is a safe and effective adjunctive treatment independent of an antihypertensive medication regimen. The data included sustained and clinically meaningful BP reductions in patients with uncontrolled hypertension who had been prescribed an average of 4.6 antihypertensive medication classes.

Reductions in office systolic BP and 24-hour ambulatory systolic BP at 3 years were –16.7 mm Hg and –9.1 mm Hg, respectively. The study demonstrated efficacy in a variety of hypertensive patients, including those prescribed a wide number and class combination of antihypertensive medication (0-3 vs ≥ 4 medications at baseline; P = .69).

Professor Felix Mahfoud, MD, a cardiologist at Saarland University Hospital in Homburg, Germany, who serves as Principal Investigator of the GSR DEFINE Registry, presented the findings at EuroPCR.

“With this new analysis, we are continuing to see Symplicity BP procedure as a significant, safe, and sustained treatment to manage hypertension, with the largest and longest reported follow-up of any trial of its kind,” commented Prof. Mahfoud in Medtronic’s press release. “These findings offer new insights into RDN BP-lowering efficacy and suggest that RDN should be considered, regardless of the medication regime.”

Earlier GSR DEFINE data were presented at the EuroPCR 2022 conference in Paris.

The European cost-effectiveness analysis for the Symplicity RDN procedure used the latest SPYRAL HTN-ON MED Full Cohort results in the context of a high-bar effectiveness threshold. The data were presented by Professor Roland Schmieder, MD, who is Professor of Internal Medicine, Nephrology, and Hypertension, Head of the Clinical Research Centre and Vice Chair of the Department of Nephrology and Hypertension at the University Hospital Erlangen, Germany.

The data demonstrated that RF RDN is projected to be cost-effective in the United Kingdom’s National Health Service health care system and substantially below the £20,000 willingness-to-pay threshold for NICE, the United Kingdom’s National Institute for Health and Care Excellence, reported Medtronic.