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ACC.24: SPYRAL HTN Clinical Program Data Show Durability of Medtronic Renal Denervation System
Atlanta, Georgia - Medtronic presented long-term durability data at the American College of Cardiology Scientific Sessions (ACC.24) that showed clinically meaningful, safe and sustained blood pressure (BP) reductions (-23.2 mmHg in office systolic BP and -14.0 mmHg reductions in 24-hour ambulatory BP) in patients with uncontrolled hypertension following the Symplicity blood pressure procedure at a mean follow up of 4.4 years (range of 3-9.4 years). The meta-analysis was composed of 18 independent reports with data over three years, and included 4,439 patients with over 12,600 patient-years of follow up. These data parallel previous findings that the Symplicity blood pressure procedure has demonstrated excellent short- and long term-safety and resulted in absolute blood pressure reductions that are remarkably consistent with its own clinical program and independent studies.
“These findings add to the largest collective meta-analysis for RDN,” said Dr. Felix Mahfoud, Prof. of Cardiology, University of Saarland, Homburg, Germany and SPYRAL HTN executive committee member. “As we continue treating patients with radiofrequency renal denervation, it’s reassuring to see the long-term benefits, as durability has been a key question in the field. It’s clear with the totality of evidence behind the procedure that it continues to be beneficial for patients for years.”
The SPYRAL HTN Clinical Program is the most rigorous and extensive patient experience of renal denervation in difficult to control hypertensive patients, those off and on anti-hypertensive medications including patients with high cardiovascular risk. The Symplicity blood pressure procedure is backed by over 4,000 patients studied in the SPYRAL HTN clinical program, with over 25,000 procedures performed worldwide.
“This analysis underscores Medtronic’s unmatched clinical leadership and commitment to investigating renal denervation on a long-term basis,” said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. “Ultimately, as we continue to commercialize Medtronic Symplicity Spyral in the U.S., uncovering more positive results about the sustained, clinically meaningful blood pressure reductions of the procedure remains a top priority, especially as hypertension rates continue to climb.”
About the Medtronic Symplicity Renal Denervation System
The Medtronic Symplicity Spyral renal denervation system, also known as the Symplicity blood pressure procedure, is an innovative, minimally invasive procedure that delivers radiofrequency energy to calm the nerves near the kidneys that can become overactive and cause elevated blood pressure. After sedation, the doctor inserts a single thin tube (known as a catheter) into the artery leading to the kidney. Once the tube is in place, the doctor administers energy to the system to calm the excessive activity of the nerves connected to the kidney. The tube is removed, leaving no implant behind.
Currently limited for investigational use in Japan and China, the Symplicity Spyral renal denervation system is approved for commercial use in more than 70 countries around the world.
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