Landmark SPYRAL HTN-OFF MED Pivotal Trial Shows Superiority for Renal Denervation in Patients with High Blood Pressure Compared to Sham Procedure

ACC.20/WCC: Study Finds Significant Blood Pressure Reductions Achieved with RDN in Absence of Anti-Hypertensive Medication 

Medtronic Receives FDA “Breakthrough Device Designation” for Symplicity Spyral Renal Denervation System

DUBLIN, March 29, 2020 (GLOBE NEWSWIRE) --  Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced first-ever clinical data from the SPYRAL HTN-OFF MED Pivotal Trial. The prospectively powered study of patients with uncontrolled high blood pressure (BP) not taking anti-hypertensive medications met its primary and secondary effectiveness endpoints, with a >99.9% probability of superiority for both versus those who received a sham control procedure. Additionally, there were no major device or procedural safety events through three months. The study was presented today as part of the American College of Cardiology together with the World Congress of Cardiology Scientific Sessions (ACC.20/WCC) and published simultaneously in The Lancet.

The global, sham-controlled study evaluated 331 patients—166 of whom were randomized to renal denervation (RDN), a minimally invasive procedure intended to regulate overactivity of nerves that lead to and from the kidney. Results showed a statistically significant 9.2 mm Hg reduction in patients’ office systolic blood pressure (OSBP) and 4.7 mm Hg reduction in 24-hour systolic ambulatory blood pressure (ABPM) at three months in those treated with the Symplicity Spyral RDN system. Blood pressure reductions were sustained consistently throughout the day and nighttime periods, which may offer an important benefit as cardiovascular risk is higher during the nighttime period. Anti-hypertensive medications (if prescribed) were discontinued for at least three weeks prior to randomization. 

“These exciting results definitively demonstrate that RDN lowers blood pressure, including over the 24-hour period,” said Prof. Michael Böhm, M.D., Ph.D., chief of cardiology at the University Hospital Homburg/Saar in Germany. “These new findings complement the broader SPYRAL Program further reinforcing RDN as a treatment option for patients with uncontrolled hypertension.”

At three months, the study showed:

•  RDN was superior to sham in all BP measures (24-hour ABPM and Office BP, systolic and diastolic).
•  RDN had significantly greater BP reductions vs. sham control in both 24-hour systolic ABPM (4.0 mmHg, p<0.001), and office systolic BP ( 6.6 mmHg, p<0.001).

“As many patients with uncontrolled hypertension struggle to adhere to lifelong drug therapy for a variety of reasons and may look to other options that complement traditional treatments, we believe this advance could help clinicians work with patients to better manage their high blood pressure,” said Dave Moeller, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic. “Medtronic is committed to the field of renal denervation and in addressing the unmet need in hypertension management globally, and we look forward to seeing more insights from our industry-leading SPYRAL HTN clinical program as we realize the full potential of the therapy.”