CMS Proposes Medicare Coverage for Renal Denervation Therapy, Paving Way for Medtronic's Strongest Growth Engine

Jul 13, 2025 11:30 CST Updated 11:30

Medtronic

Medical Device Manufacturer

Released by the Centers for Medicare & Medicaid Services (CMS)New RDN Medical InsuranceProposal. NewThe proposal suggests including RDN in the medical insurance coverage for patients with uncontrolled hypertension. The proposal has initiated a 30-day public comment period, and the final decision is expected to be announced on or before October 8, 2025.

New RDN Medical InsuranceProposalAmong the 81 pieces of feedback collected in the first round, the majority were clinical case reports provided by doctors, confirming the positive efficacy of the therapy. It can be said that the success rate is very high.

Medtronic Evaluation

"We are pleased to see CMS's national Medicare coverage decision for Symplicity Spyral. This milestone marks a critical step in advancing innovative therapies for hypertension to benefit more patients — hypertension being a public health crisis currently faced by the U.S. The current CMS proposal will provide many Medicare patients in the U.S. who need RDN therapy with access to treatment, and we thank CMS for their relentless efforts in creating new pathways to accelerate the clinical application of breakthrough technologies."

---Jason Weidman Senior Vice President and President of Medtronic Coronary and Renal Denervation Business

Recor Medical Evaluation

"CMS's proposed decision to include uRDN in Medicare coverage for patients with uncontrolled hypertension is exciting --- this group still has significant unmet medical needs. This preliminary decision represents substantial progress in recognizing the clinical value of RDN, which will help expand access to this therapy."

---Lara BarghoutRecor Medical CEO

According to the World Health Organization (WHO) 2025 report, there are approximately 1.3 billion people with hypertension globally, nearly half of whom are not effectively controlled. China has the largest number of hypertensive patients, about 245 million. The United States is the world's largest medical market.It has 18 millionHypertensive patients cannot effectively control their condition through medication and lifestyle improvements. Once CMS'sNew RDN Medical InsuranceThe proposal has been passed, which will kick off the biggest celebration in the history of the medical device industry.

Currently, the FDA has approvedMedtronicMedtronic andRecor Medical's RDN product launch. Following this, Boston Scientific (which recently spent $600 million on an acquisition this year).SoniVie, ObtainuRDN Technology), Ablative Solutions and other companies are actively promoting clinical research. As Medtronic is the pioneer of RDN technology, it not only possesses the largest clinical research data but also has a strong sales team; therefore, Medtronic is the most favored in the market.

Market Evaluation

If CMS finally approves the Medicare coverage decision for renal denervation, this therapy is expected to become "one of the strongest growth engines in Medtronic's history."Although it is currently only at the proposal stage, we believe this positive signal marks a crucial first step in the commercialization process of the Symplicity system.

---William Blair

"Although the decision was in line with expectations, it remains positive for Medtronic, which is advancing its hypertension outpatient program through Symplicity Spyral and actively pursuing medical insurance coverage. The widespread support for medical insurance coverage, along with CMS's decision, has opened up a vast potential patient population for Medtronic."

---BTIG

Medtronic is the biggest supporter of treating hypertension through vascular ablation surgeries. It not only spent $800 million to acquire Ardian and obtain RDN technology 15 years ago, but also continued to invest heavily in redesigning the product and initiating new clinical studies despite the major failure of RDN trials in 2014. It has been burning money for 10 years on Symplicity Spyral.l to the market. Following the launch of Symplicity Spyral, research on combined renal and hepatic denervation was initiated, pushing hypertension treatment to new heights. More patients with high medical needs will be treated with advanced ablation technology, avoiding disease progression, improving quality of life, and extending lifespan.

If the new increase is passed, it will also promote the rapid development of RDN in China. At present, patients with hypertension can only control blood pressure by taking antihypertensive drugs (required daily).(taking antihypertensive drugs), which is a huge investment for health insurance. Now, subsequent evidence shows that RDN not only has clinical value, but alsoSocioeconomic Value. RDN Will Receive Significant Support from Health Insurance.Currently NMPA has approved the market entry of four RDN products from Medtronic, Antong, and others. These companies are poised for significant growth, with Antong's RDN product being the only one to receive approval from both NMPA and CE. This will enable Antong to capture a larger market share and potentially challenge Medtronic overseas.