Medtronic (NYSE: MDT) and Recor Medical both issued statements supporting new Medicare coverage for their respective renal denervation therapies.
Both companies offer renal denervation (RDN) technologies for treating hypertension. Recor Medical received a landmark FDA nod for its Paradise ultrasound RDN (uRDN) system in November 2023. Medtronic, the second company with such approval, picked up its nod for the Symplicity Spyral system just weeks later. The companies also have ongoing patent litigation related to their RDN systems.
Now, both should benefit from a new Centers for Medicare & Medicaid Services (CMS) proposed National Coverage Determination (NCD). CMS recommends coverage for uRDN and radiofrequency renal denervation (rfRDN) for uncontrolled hypertension.
The proposed NCD initiates a 30-day public comment period, with the final posting expected on or before Oct. 8, 2025.
Commentary from Medtronic and Recor officials
Medtronic SVP and President of the Coronary and Renal Denervation business, Jason Weidman, said:
“We are pleased to see CMS’ proposed National Coverage Determination for the Symplicity Spyral renal denervation system. This milestone is an important step towards expanding patient access to this innovative treatment for hypertension, a public health crisis in the U.S. The proposed NCD from CMS – as it stands today – will provide many U.S. Medicare patients in need with access to RDN. We recognize and thank CMS for their ongoing efforts in creating new pathways to expedite access to breakthrough technologies.”
Lara Barghout, CEO of Recor, said:
“We are encouraged by CMS’s proposed decision to provide Medicare coverage for uRDN in patients with uncontrolled hypertension—a population that continues to face significant unmet need. This preliminary determination is a meaningful step forward in recognizing the clinical value of RDN and will aid in expanding access to the patients who need it.”
The analysts’ take
BTIG analysts Ryan Zimmerman and Iseult McMahon maintain a “Neutral” rating for Medtronic following this news. Recor, a private company, isn’t rated by the analysts.
The analysts say the news is a positive, though.
“Even though this was anticipated we think it’s still a win for Medtronic, who has been preparing sites for coverage with the launch of Symplicity Spyral as it ramps up outpatient hypertension programs,” the analysts wrote. “There has been an outpouring of support for coverage. The [CMS decision] opens up MDT to a massive potential patient pool.”
