CMS Finalizes National Coverage for Medtronic’s Symplicity Spyral RDN

Medtronic announced that the Centers for Medicare & Medicaid Services (CMS) released the final National Coverage Determination (NCD) on renal denervation, which applies to the Symplicity Spyral renal denervation (RDN) system.

Now, Medicare patients will have access to the Symplicity blood pressure procedure to treat uncontrolled hypertension.

The Symplicity Spyral RDN system was approved by the U.S. Food and Drug Administration (FDA) in November 2023. It is a minimally invasive procedure that delivers radiofrequency (RF) energy to nerves around the kidneys that can become overactive and contribute to high blood pressure.

After sedation, the physician inserts a catheter into the artery leading to the kidney. Once the tube is placed, energy is administered to the system to calm the excessive activity of the nerves near the kidney. The tube is then removed, leaving no implant behind.

“We are very pleased with the final national coverage determination, which opens up patient access to renal denervation with the Symplicity Spyral RDN system, a safe and durable blood pressure-lowering procedure for patients who have not succeeded with medication or lifestyle changes alone,” said Jason Weidman, senior VP and president of Medtronic’s Coronary & Renal Denervation business. “This milestone enables physicians to offer patients more choices when managing hypertension, potentially leading to better outcomes for a population in urgent need of new options. We congratulate CMS and recognize all the work it took to get to this point.”

At this year’s Transcatheter Cardiovascular Therapeutics (TCT) conference, the company announced long-term results from its final report of the SPYRAL HTN-ON-MED randomized clinical trial that showed patients treated with the Symplicity Spyral renal denervation (RDN) procedure had significantly greater reductions in blood pressure compared to sham patients through three years.

“We’re proud to be at the forefront of expanding access to minimally invasive therapies and advancing hypertension treatment,” said Skip Kiil, executive VP and president of the Medtronic Cardiovascular portfolio. “This determination represents a significant opportunity to improve care for patients and opens a novel and meaningful market for Medtronic, positioning our renal denervation technology as one of the most exciting growth drivers for the company. Our commercial teams will be actively leveraging this milestone, collaborating closely with healthcare providers and hypertension centers as we accelerate the adoption of this transformative growth opportunity for Medtronic.”