Medtronic Presents Renal Denervation Data From Global SYMPLICITY Registry and Launches GSR-DEFINE Study

May 18, 2021—Medtronic announced that new clinical data from the Global SYMPLICITY Registry (GSR) indicating that renal denervation (RDN) with the company’s Symplicity system was associated with clinically significant and sustained blood pressure reductions in a real-world population of patients with hypertension (HTN) through 3 years. GSR is a prospective, single-arm, global, observational study that analyzed approximately 3,000 patients with uncontrolled HTN and other comorbidities typical in HTN patients (eg, chronic kidney disease, diabetes).

The GSR results were presented in a Late-Breaking Clinical Trial session at the virtual 2021 EuroPCR annual meeting.

Also at the EuroPCR meeting, Medtronic announced the launch of the GSR-DEFINE study. This new phase of patient data collection aims to enroll an additional 2,000 patients with uncontrolled hypertension, who will be treated with the Medtronic Symplicity Spyral multielectrode RDN catheter. The study will collect data for a subgroup of patients out to 5 years. Approved for commercial use in more than 60 countries around the world, the Symplicity Spyral RDN system is limited to investigational use in the United States, Japan, and Canada.

Felix Mahfoud, MD, a cardiologist at Saarland University Hospital in Homburg, Germany, is Principal Investigator of the GSR study. Dr. Mahfoud commented in Medtronic’s announcement, “As we continue to expand our clinical data around renal denervation for uncontrolled hypertension management, we wanted to broaden our understanding of the long-term benefits for our patients who suffer from multiple chronic conditions and are typically prescribed multiple medications. With this new analysis, we can now help patients continue to see the real-world benefits of renal denervation.”

According to Medtronic, patients in the GSR study were treated with the Symplicity RDN system utilizing the single electrode Symplicity catheter or the Symplicity Spyral multielectrode catheter. The outcomes were analyzed up to 3 years postprocedure.

The company reported that the GSR study results demonstrated that the Symplicity system led to significant and clinically meaningful reductions in blood pressure that were sustained out to 3 years postprocedure. Patients experienced a mean reduction of 16.7 mm Hg office systolic blood pressure (OSBP) at 3 years compared to baseline.

Investigators also evaluated the benefit of RDN within various patient subgroups using a clinical composite endpoint; a retrospective analysis composed of both OSBPs, 24-hour ambulatory blood pressure, and medication burden. They found a consistent benefit of RDN in patients with versus without diabetes, chronic kidney disease, or patients who were aged 65 years and above, stated Medtronic.

Medtronic noted that the similar clinical composite endpoint was used in a recent study that showed patients were nearly three times more likely to benefit from RDN compared to remaining on a regime of antihypertensive medications alone (win ratio = 2.78; P < .001), which was published by David E. Kandzari, MD, et al in EuroIntervention (2021;16:e1496-e1502).

Also at EuroPCR, Medtronic advised that investigators reported a new analysis estimating the reduction in clinical events in patients treated with the Symplicity RDN system. The analysis used the clinical events observed at 3 years in the GSR and put these in perspective with a modeled control. The results showed a 26% relative risk reduction in major cardiovascular events over 3 years for the full study cohort treated with RDN, and a 34% reduction for patients with resistant hypertension over the same timeframe.