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June 25, 2020

Medtronic’s Global SYMPLICITY Registry Shows Sustained Lower Blood Pressure After Renal Denervation

June 25, 2020—Medtronic reported new data from the Global SYMPLICITY registry (GSR), which showed that renal denervation (RDN) with the Medtronic Symplicity RDN system significantly reduced blood pressure (BP) in uncontrolled hypertension patients out to 3 years independent of antihypertension medication burden. The data were presented virtually by Felix Mahfoud, MD, as part of the PCR e-Course 2020.

According to Medtronic, the study showed that RDN led to significant and clinically meaningful reductions in BP that were sustained out to 3 years postprocedure (17 mm Hg office systolic BP), with more patients achieving BP below 140 mm Hg and those at very high BP levels experiencing drops into lower risk BP ranges.

The findings included:

  • The number of patients at the very highest BP level (> 180 mm Hg systolic at baseline) dropped by two-thirds at 3 years.
  • The number of patients who had reported office systolic BP < 140 mm Hg increased from 13% at baseline to 39% at 3 years.
  • BP drops occurred while patients were prescribed an average of ≥ four antihypertensive medications, which remained unchanged over 3 years.
  • The absence of increase in medications suggests that the effect of RDN was independent of antihypertensive medication burden.
  • RDN continued to show a strong safety profile at 3 years with an incidence of renal artery stenosis of 0.3%, which is within the expected range for patients with hypertension not undergoing denervation.

“In the largest real-world study of patients receiving RDN, we are seeing significant and clinically meaningful reductions in both office and 24-hour BP sustained out to three years postprocedure, which demonstrates the durability of RDN,” commented Dr. Mahfoud in Medtronic’s announcement. “These data reinforce that RDN is a viable, complementary option with positive effects on hypertensive patients without requiring an increase in medication burden over time.” Dr. Mahfoud is a cardiologist at Saarland University Medical Center in Homburg, Germany.

The data presented at PCR closely mirror GSR data that were recently published by Dr. Mahfoud, et al in Journal of the American College of Cardiology, which showed lasting results with RDN in a variety of high-risk patients, including those with diabetes, chronic kidney disease, isolated systolic hypertension, or resistant hypertension (2020;75:2879-2888).

The GSR is the largest study documenting the long-term safety and effectiveness of the Medtronic RDN systems in a real-world setting in patients with uncontrolled hypertension. To date, the registry has enrolled more than 2,860 patients treated with RDN and includes 3-year follow-up for more than 2,500 patients, noted the company.

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