Medtronic plc today announced long-term data from the first 80 patients in the SPYRAL HTN-ON MED trial, which were presented today 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.
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 Medtronic Symplicity Spyral system in hypertensive patients prescribed one to three anti-hypertensive medications. The long-term ON MED data presented at ACC.22 studied the same cohort of patients as the six-month primary endpoint analysis that was previously published in The Lancet in 2018.
Medtronic completes randomization in the full cohort of its SPYRAL HTN-ON MED Trial
Medtronic also announced it recently completed randomization for the full cohort of its SPYRAL HTN-ON MED trial and closed enrollment. The full analysis cohort targets up to 340 randomized patients. Medtronic expects the six-month post procedure follow-up for the full cohort will be complete in the second half of calendar year 2022.
“The data presented at ACC underscores Medtronic’s confidence in RDN as a solution for the millions of people who suffer from uncontrolled high blood pressure. These new data will be important to regulatory officials, clinicians and payers as we look to bring a new treatment option to market for patients with uncontrolled hypertension,” said Jason Weidman, senior vice president and president of the Coronary & Renal Denervation business unit, which is part of the Cardiovascular Portfolio at Medtronic. “Looking ahead, we remain focused on the anticipated six-month follow up for the full cohort of the ON MED trial in the second half of this calendar year.”
The SPYRAL HTN-ON MED trial is part of the SPYRAL HTN Global Clinical Program, adding to the safety and efficacy data for RDN. Along with the real-world data from the Global Symplicity Registry, when combined with commercial experience, there have been more than 20,000 procedures performed with Medtronic RDN technology. The clinical program is backed by the most rigorous and extensive patient experience studied in the presence and absence of medication and in patients with high baseline cardiovascular risk.