Medtronic’s Symplicity Spyral RDN System Studied at 3 Years in SPYRAL HTN-ON MED Trial

April 4, 2022—Medtronic announced long-term data from the first 80 patients in the SPYRAL HTN-ON MED trial, which demonstrated that patients who were prescribed antihypertensive medications and treated with the company’s Symplicity Spyral renal denervation (RDN) system continued to show durable, clinically significant blood pressure reductions through 3 years.

SPYRAL HTN-ON MED is a global, randomized, sham-controlled trial investigating the blood pressure–lowering effect and safety of RDN with the radiofrequency-based Symplicity Spyral system in hypertensive patients prescribed one to three antihypertensive medications.

The data were presented during a featured clinical research session at ACC.22, the American College of Cardiology’s 71st annual scientific session held April 2-4 in Washington, DC. The data were simultaneously published online by Professor Felix Mahfoud, MD, et al in The Lancet.

The long-term ON MED data presented at ACC.22 studied the same cohort of patients as the 6-month primary endpoint analysis that was published in 2018 by David E. Kandzari, MD, et al in The Lancet (2018;391:2346-2355), noted the company.

Medtronic also announced it recently completed randomization for the full cohort of the SPYRAL HTN-ON MED trial and closed enrollment. The full analysis cohort targets up to 340 randomized patients. Additionally, Medtronic expects the 6-month postprocedure follow-up for the full cohort will be complete in the second half of calendar year 2022.

According to Medtronic, the data from the first 80 patients at 3 years included the following:

• 18.7 mm Hg reduction in RDN patients versus 8.6 mm Hg in sham for 24-hour systolic ambulatory blood pressure
• 20.9 mm Hg reduction in RDN patients versus 12.5 mm Hg in the sham arm for office systolic blood pressure

Prof. Mahfoud, who is a cardiologist at Saarland University Hospital in Homburg, Germany, is a member of the SPYRAL HTN executive committee.

In the company’s press release, Prof. Mahfoud commented, “Across the latest trials, consistent blood pressure reductions have been observed in patients with uncontrolled hypertension treated with the Medtronic Symplicity Spyral RDN system. For the first time, we now have randomized data that demonstrate that in a typical patient population—hypertension patients who are on antihypertensive medications and treated with RDN—we are seeing the continued, long-term blood pressure–lowering effect. Lowering blood pressure can have meaningful clinical results for patients, including a decrease in the risk of cardiovascular events.”

Medtronic advised that the trial also demonstrated procedural and long-term safety with the Symplicity Spyral RDN catheter, with zero major device or procedural safety events through 3 years.

The Symplicity Spyral device is limited to investigational use in the United States, Japan, and Canada. It is approved for commercial use in more than 60 countries around the world.