Dive Brief:
- The Centers for Medicare and Medicaid Services on Thursday posted a proposed national coverage determination for renal denervation, a new procedure for lowering blood pressure in people with uncontrolled hypertension.
- Medtronic and Recor Medical, a subsidiary of Otsuka Medical Devices, obtained Food and Drug Administration approval for the first-of-a-kind treatments in late 2023, with Medtronic’s Symplicity Spyral device overcoming resistance from an advisory panel of outside experts to ultimately win the FDA’s backing.
- William Blair analyst Brandon Vazquez said a CMS national coverage decision for renal denervation could pave the way for the treatment to become “one of the largest growth drivers in recent history” for Medtronic, noting the device maker has estimated more than 18 million people in the U.S. have high blood pressure that is not well managed with medication and lifestyle changes. “While this is only a proposed rule, we view the positive readout as a meaningful first step toward Symplicity’s ramp-up,” Vazquez wrote in a report to clients Friday.
Dive Insight:
Medtronic and Recor have had renal denervation programs in development for more than a decade. Medtronic’s device delivers radiofrequency energy to the nerves leading to the kidneys to disrupt overactive signaling that can lead to hypertension, while Recor’s system, called Paradise, uses ultrasound energy.
Boston Scientific is also interested in entering the market. The company in March said it agreed to pay up to $540 million to acquire SoniVie, which is developing an ultrasound-based renal denervation system called Tivus. A pivotal trial for the device is underway.
The proposed CMS determination recommends Medicare coverage for both radiofrequency- and ultrasound-based renal denervation.
Recor CEO Lara Barghout called the CMS proposal encouraging for a patient population that continues to face significant unmet need. “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 said Thursday in a statement.
Jason Weidman, president of Medtronic’s coronary and renal denervation business, similarly applauded the proposal, characterizing hypertension as a public health crisis in the U.S.
Medtronic prevailed in bringing Symplicity Spyral to market after facing concerns and a negative vote from the FDA’s advisory committee in 2023 over the device’s benefit-risk profile following a clinical trial that failed to meet its primary endpoint.
The CMS proposal opens a second 30-day public comment period. Of the 81 comments submitted in the first period, the agency said the majority were anecdotes from physicians who used renal denervation among their patients and spoke positively of its use.
The agency said it expects to post its final decision memorandum in October.
