CMS today issued its final National Coverage Determination (NCD) on renal denervation (RDN), marking a major win for Medtronic (NYSE: MDT) and Recor Medical.
Both companies develop their own RDN systems. Recor Medical received the first FDA nod for its Paradise ultrasound RDN (uRDN) system in November 2023. Medtronic, the second company with such approval, won approval for the Symplicity Spyral system just weeks later. The companies have ongoing patent litigation related to their RDN systems as well.
In July, both companies applauded CMS’s planned coverage for their technologies when it proposed the NCD for uncontrolled hypertension. At the time, they anticipated a decision on Oct. 8, but it came 20 days later.
The slightly later-than-expected decision now offers Medicare patients access to the RDN technology for the treatment of uncontrolled hypertension, also known as high blood pressure. To add to the Medicare win, in August, the American College of Cardiology (ACC) and American Heart Association (AHA) updated their hypertension guidelines to include RDN as a treatment option for certain patients with resistant or uncontrolled high blood pressure.
Both Medtronic and Recor continue to deliver milestones for the RDN technologies as well. This week, Medtronic shared two separate studies at TCT 2025 outlining the success of Symplicity Spyral. One highlighted sustained blood pressure reductions, while the other study demonstrated effectiveness in a high-risk cohort.
Recor, meanwhile, built on its U.S. success with Japanese regulatory approval for Paradise in August. Approval made it the first RDN treatment available in the country.
Commentary from Medtronic and Recor officials
Jason Weidman, SVP and president of the Coronary & Renal Denervation business at Medtronic, said:
“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. 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.”
Skip Kiil, EVP and president of the Medtronic Cardiovascular portfolio, said:
“We’re proud to be at the forefront of expanding access to minimally invasive therapies and advancing hypertension treatment. 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.”
Lara Barghout, CEO of Recor Medical, said:
“I would like to commend CMS for all the effort it took to issue this NCD. This is a transformative milestone for patients across the U.S. who continue to battle uncontrolled hypertension,” said Lara Barghout, CEO of Recor Medical. “By formally recognizing the proven clinical value of renal denervation and extending Medicare coverage, CMS is paving the way for broader, more equitable access to this breakthrough therapy. This decision not only reinforces the robust body of evidence supporting the Paradise uRDN system as a safe and effective adjunctive treatment but also delivers renewed hope to patients striving for better hypertension control and improved cardiovascular health.”
Helen Reeve-Stoffer, Recor chief clinical officer, said:
“This CMS coverage decision represents a powerful recognition of the rigorous body of evidence supporting the Paradise uRDN system. Years of clinical research have demonstrated the impact of the Paradise uRDN system in lowering blood pressure in patients with uncontrolled hypertension, one of the most persistent challenges in cardiovascular medicine.”
The analysts’ take
BTIG analysts Ryan Zimmerman and Iseult McMahon said the decision, while delayed a few weeks, came as expected. They highlight the current U.S. government shutdown as a reason for the late finalization.
The analysts note an important aspect of the final decision memo that differs from the proposal. In the proposal, CMS required patients to follow guideline-directed medical therapy for at least three months. In the final decision, CMS reduced this to six weeks, cutting the medical management criteria in half.
Zimmerman and McMahon said this “arguably is better than expected as it allwos for a faster pathway to RDN than originally proposed.” They say that around 64% of Medicare claims had a hypertension diagnosis in fiscal year 2021, and nearly half of all U.S. adults have hypertension (with 25% not under control).
“It’s a large market opportunity to say the least,” the analysts wrote.
