FDA Approves Medtronic's Minimally Invasive Device for Hypertension Treatment

The Symplicity Spyral™ renal denervation (RDN) system, also known as the Symplicity™ blood pressure procedure, has been approved by the United States Food and Drug Administration (FDA) for the treatment of hypertension. This innovative procedure delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure. The procedure involves inserting a single thin tube (catheter) into the artery leading to the kidney, administering energy to calm the excessive activity of the nerves connected to the kidney, and then removing the tube, leaving no implant behind.

Hypertension is a leading modifiable cause of heart attack, stroke, and death, with notably worse prevalence in underserved U.S. populations. Despite available medications and lifestyle interventions, control rates remain low, highlighting the need for additional treatment options.

Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business at Medtronic, emphasized the company's commitment to this therapy, stating, "High blood pressure is a global health issue, and patients need more options to manage their blood pressure."

The approval is based on the Medtronic SPYRAL HTN Global Clinical Program, the most comprehensive clinical program studying RDN, which includes experience in more than 25,000 patients treated globally. David Kandzari, M.D., chief of the Piedmont Heart Institute and Cardiovascular Service, noted the procedure's safety and effectiveness, providing significant 'always on' blood pressure reductions for patients.

Patient preference and shared decision-making are critical components of developing a hypertension care plan, including the Symplicity blood pressure procedure. A Medtronic-led patient preference study found that approximately one third of patients were likely to choose an interventional treatment with blood pressure reduction and potential risks in line with those of the Symplicity blood pressure procedure.

Raymond Townsend, M.D., from the University of Pennsylvania School of Medicine, highlighted the procedure's potential to transform hypertension treatment, offering a solution that complements medication and lifestyle changes, especially for patients seeking additional approaches to manage their blood pressure.

The Symplicity Spyral Renal Denervation System is approved for commercial use in more than 70 countries worldwide, although it is currently limited for investigational use in Japan, China, and Canada.