September 19, 2022 – Medtronic plc announced long-term results from the SYMPLICITY HTN-3 clinical trial. Subjects who underwent radiofrequency renal denervation (RF RDN) with the first generation Symplicity renal denervation system, had a statistically significant reduction in office and ambulatory blood pressure compared to subjects in the sham control group.
“In this long-term follow-up from the SYMPLICITY HTN-3 trial, we observed significant reductions in the blood pressures of patients who underwent treatment with renal denervation, with no long-term complications emerging from this minimally invasive procedure,” said Deepak L. Bhatt, M.D., M.P.H., executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School; and co-principal investigator for the SYMPLICITY HTN-3 trial. “These findings provide important insights into the evolution of patients’ blood pressure control, with and without renal denervation, in a scenario more akin to the real-world setting— under everyday physician management without the frequent follow up visits and monitoring that occur in research settings. The results illustrate that for certain patients with high blood pressure, despite attempts to adhere to multiple medications and modify their lifestyles, their blood pressure remains poorly controlled, putting them at risk for cardiovascular complications such as stroke.”
This latest analysis of the SYMPLICITY HTN-3 trial examined the long-term safety and efficacy of RDN in hypertensive patients who were on antihypertensive medications and received treatment with the Symplicity blood pressure procedure.
Approved for commercial use in more than 60 countries around the world, the Symplicity Spyral renal denervation system is limited to investigational use in the United States, Japan, and Canada.