The Symplicity Spyral Renal Denervation System received marketing approval from the U.S. Food and Drug Administration (FDA) to treat hypertension, Medtronic announced Friday. “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," said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic, in a news release. “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.” With a minimally invasive procedure, the device delivers radiofrequency energy to renal nerves, which can become overactive and contribute to hypertension. After sedation, a clinician inserts a catheter into the renal artery and administers energy to the system to calm the nerves’ excessive activity. The tube is then removed, and no implant id left behind. “This approval paves the way for a transformation in hypertension treatment, offering a solution that complements medication and lifestyle changes,” said Raymond Townsend, MD, of University of Pennsylvania Perelman School of Medicine and 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.” The FDA designated Symplicity Spyral as a breakthrough device in March 2020. Two randomized controlled trials, SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED, were used to support Medtronic’s premarket approval application. The announcement follows a meeting of the FDA’s Circulatory System Devices Panel in August that gave the device mixed reviews. The panel unanimously agreed that the system is safe, but it agreed by a 7-6 margin that the device is effective. The panel deadlocked on the question of whether the system’s benefits outweighed the risks, 6-6 with one abstention. Panel Chair Richard Lange, MD, MBA, the endowed president of the Texas Tech University Health Sciences Center Paul L. Foster School of Medicine in El Paso, cast the tiebreaking “no,” vote, meaning the final tally was 7-6, with one abstention, saying the benefits did not outweigh the risks. This is the second interventional treatment device the agency has approved this month. Recor Medical’s Paradise Ultrasound Renal Denervation received FDA marketing approval on Nov. 7. Image Credit: Medtronic Image Caption: Symplicity Spyral Renal Denervation System