In a significant win for hypertension patients, the Centers for Medicare & Medicaid Services (CMS) has approved Medicare reimbursement for renal denervation systems from Medtronic and Recor Medical. This decision, effective January 1, 2025, is set to provide patients with greater access to innovative treatments for high blood pressure resistant to medication.
The CMS approval includes separate transitional pass-through (TPT) payments and unique device codes for both companies, covering the outpatient procedures needed for these advanced therapies. These TPT payments will be available for up to three years, enabling Medicare beneficiaries to access these treatments while CMS evaluates their potential for long-term coverage.
Both Medtronic’s Symplicity Spyral and Recor’s Paradise renal denervation systems received FDA approval in November 2023. Their development has spanned more than a decade, with industry projections suggesting the technology could become a multibillion-dollar market.
Recor Medical, now under Otsuka Medical Devices, began working on the Paradise system in 2009. The ultrasound-based device targets nerves lining the main blood vessels to the kidneys, which can drive up blood pressure when stimulated. “This TPT designation acknowledges that Paradise’s ultrasound technology is highly differentiated, and it opens access to an effective treatment for patients who haven’t found relief through lifestyle or medication alone,” said Lara Barghout, President and CEO of Recor.
Meanwhile, Medtronic’s Symplicity Spyral uses radiofrequency ablation to achieve similar results. Despite early clinical challenges, the company revised the device in 2020 and has since demonstrated lasting blood pressure reductions. In a recent trial presented at the TCT conference in Washington, D.C., Symplicity showed sustained benefits, with blood pressure reductions persisting up to two years even among patients on multiple anti-hypertensive drugs.
Jason Weidman, President of Medtronic’s coronary and renal denervation division, noted the impact of CMS’s TPT approval: “This approval marks an important step for Symplicity, as it lowers financial barriers for healthcare systems and supports broader access to this breakthrough treatment for patients suffering from uncontrolled hypertension.”
Looking ahead, Medtronic also announced plans to explore Symplicity’s potential for broader applications, including liver artery denervation, underscoring the company’s commitment to expanding its therapeutic reach in hypertension care.
