Medtronic’s Symplicity Spyral Renal Denervation System Gains FDA Approval for Hypertension Treatment

November 17, 2023—Medtronic announced it has received United States Food and Drug Administration (FDA) approval for its Symplicity Spyral Renal Denervation System for the treatment of hypertension. The company plans to begin United States commercialization immediately.

The Symplicity procedure denervates the renal arteries using radiofrequency energy to reduce blood pressure. Medtronic’s SPYRAL HTN Global Clinical Program includes more than 25,000 patients over 10 years of study, including those both on and off blood pressure medications. A patient preference study was also conducted, which the company notes showed that when presented with an interventional treatment with blood pressure reduction and potential risks in line with those of the procedure, approximately one-third of patients were likely to choose the intervention.

Results from Medtronic’s clinical program were presented at a 2-day FDA advisory panel session in August 2023, along with those of Recor Medical, which has also gained approval for its renal denervation system.

“The Symplicity blood pressure procedure is safe and effective, providing significant ‘always on’ blood pressure reductions for patients,” said David Kandzari, MD, in Medtronic’s announcement. Dr. Kandzari is Chief of Piedmont Heart Institute and Cardiovascular Service and Co-Principal Investigator of the SPYRAL clinical program. “This landmark approval is the culmination of rigorous scientific study and clinical trials, including long-term, sham-controlled studies in the presence and absence of medication, and the largest real-world study.”

“This approval paves the way for a transformation in hypertension treatment, offering a solution that complements medication and lifestyle changes,” added Raymond Townsend, MD, in the release. Dr. Townsend is from the Hypertension Section in the Department of Internal Medicine / Renal, at the University of Pennsylvania School of Medicine. He is also Co-Principal Investigator of the SPYRAL clinical program. “The Symplicity blood pressure procedure is a promising treatment option for clinicians and patients alike and offers opportunity to fulfill a significant unmet need in hypertension care, especially for those patients who are desperately seeking additional approaches to get their blood pressure down.”

“Our treatment options are limited for hypertensive patients, and we need another approach,” said Eric A. Secemsky, MD, in comments to Cardiac Interventions Today. “I couldn’t be more thrilled to see the approval of two renal denervation devices. I truly hope renal denervation can help improve patient care and outcomes among those diagnosed with hypertension.” Dr. Secemsky is Director of Vascular Intervention at Beth Israel Deaconess Medical Center; Section Head, Interventional Cardiology and Vascular Research; Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology; and Assistant Professor of Medicine at Harvard Medical School in Boston, Massachusetts.

“Medtronic has always believed in the potential of this therapy. We partnered closely with leading experts in our clinical community who could help us in our journey to get this technology to the people who need it most,” added Medtronic’s Jason Weidman in the company’s announcement. Mr. Weidman is Senior Vice President and President of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. “It was the promise of this therapy that enabled Medtronic to keep going, even when others exited the renal denervation space. High blood pressure is a global health issue, and patients need more options to manage their blood pressure. The approval of the Symplicity blood pressure procedure represents a significant milestone for physicians and patients in the treatment of hypertension.”