CMS Proposes Medicare Coverage for Renal Denervation Devices to Treat Uncontrolled Hypertension

Key Insights

• The Centers for Medicare and Medicaid Services has proposed national coverage for renal denervation procedures, marking a significant step toward expanding access to this innovative hypertension treatment.
• Medtronic and Recor Medical received FDA approval for their renal denervation devices in late 2023, with Medtronic's Symplicity Spyral using radiofrequency energy and Recor's Paradise system utilizing ultrasound technology.
• The proposed coverage could benefit over 18 million Americans with poorly controlled hypertension, potentially making renal denervation one of the largest growth drivers in recent medical device history.

The Centers for Medicare and Medicaid Services has proposed national Medicare coverage for renal denervation, a minimally invasive procedure designed to treat uncontrolled hypertension by targeting overactive kidney nerves. The Thursday announcement represents a crucial milestone for device manufacturers Medtronic and Recor Medical, whose technologies received FDA approval in late 2023.

FDA-Approved Technologies Show Promise

Medtronic's Symplicity Spyral device delivers radiofrequency energy to disrupt nerve signaling that contributes to elevated blood pressure, while Recor Medical's Paradise system employs ultrasound energy for the same therapeutic purpose. Both companies have invested more than a decade in developing their renal denervation programs.

William Blair analyst Brandon Vazquez highlighted the significant market potential, noting that Medtronic estimates more than 18 million people in the U.S. have high blood pressure that remains poorly managed despite medication and lifestyle interventions. "While this is only a proposed rule, we view the positive readout as a meaningful first step toward Symplicity's ramp-up," Vazquez wrote, suggesting the treatment could become "one of the largest growth drivers in recent history" for Medtronic.

Overcoming Regulatory Challenges

Medtronic's path to approval faced significant hurdles, including concerns from the FDA's advisory committee in 2023 regarding the device's benefit-risk profile. The advisory panel voted negatively on the device following a clinical trial that failed to meet its primary endpoint. Despite this resistance from outside experts, Medtronic ultimately secured FDA backing for the Symplicity Spyral system.

Industry Response and Market Expansion

Recor CEO Lara Barghout characterized the CMS proposal as encouraging for patients facing significant unmet medical needs. "This preliminary determination is a meaningful step forward in recognizing the clinical value of [renal denervation] and will aid in expanding access to the patients who need it," Barghout stated.

Jason Weidman, president of Medtronic's coronary and renal denervation business, similarly welcomed the proposal, describing hypertension as a public health crisis in the United States.

Competitive Landscape

Boston Scientific has also entered the renal denervation market, agreeing in March to acquire SoniVie for up to $540 million. SoniVie is developing the Tivus ultrasound-based renal denervation system, which is currently undergoing pivotal trials.

Public Comment Process

The CMS proposal has initiated a second 30-day public comment period. During the initial comment period, 81 submissions were received, with the majority consisting of anecdotes from physicians who had used renal denervation in their patients and reported positive experiences with the treatment.

The proposed coverage determination encompasses both radiofrequency- and ultrasound-based renal denervation technologies, potentially establishing a new standard of care for patients with treatment-resistant hypertension.