On April 4, 2022, Medtronic unveiled long-term data from the first 80 patients in the SPYRAL HTN-ON MED trial, which were presented at the American College of Cardiology's 71st Annual Scientific Session (ACC.22) late-breaking featured clinical research sessions. The data were also simultaneously published in The Lancet.
In the first 80 patients of the SPYRAL HTN-ON MED trial, the data demonstrated that patients who were prescribed anti-hypertensive medications and treated with the Medtronic Symplicity Spyral Renal Denervation (RDN) System continued to show durable, clinically significant blood pressure reductions through three years.
At three years:
- 18.7 mmHg reduction in RDN patients versus 8.6 mmHg in sham for 24-hour systolic ambulatory blood pressure (ABPM)
- 20.9 mmHg reduction in RDN patients versus 12.5 mmHg in the sham arm for office systolic blood pressure (OSBP)
"Across the latest trials, consistent blood pressure reductions have been observed in patients with uncontrolled hypertension treated with the Medtronic Symplicity Spyral RDN system," said Felix Mahfoud, M.D., cardiologist at Saarland University Hospital in Homburg, Germany, and member of the SPYRAL HTN executive committee. "For the first time, we now have randomized data that demonstrates that in a typical patient population – hypertension patients who are on anti-hypertensive 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."
The trial also demonstrated procedural and long-term safety with the Symplicity Spyral renal denervation catheter, with zero major device or procedural safety events through three years.
"With the ON MED randomized data presented and published today, Medtronic has now demonstrated the long-term benefit of renal denervation against a backdrop of an anti-hypertensive medication, with continued demonstration of a safe procedure," said Jeffrey Popma, M.D., chief medical officer for the Coronary & Renal Denervation business and the Structural Heart & Aortic business, which are part of the Cardiovascular Portfolio at Medtronic. "This highlights the importance of additional treatment options such as renal denervation."
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.