PitchBook-创新焦点：肾去极化（英）

1PitchBook Data, Inc.Nizar Tarhuni Executive Vice President of Research and Market IntelligencePaul Condra Global Head of Private Markets ResearchJames Ulan Director of Emerging Technology ResearchInstitutional Research GroupAnalysisAaron DeGagne, CFA Senior Research Analyst, Healthcare aaron.degagne@pitchbook.comDataSara Good Data Analystpbinstitutionalresearch@pitchbook.comPublishingDesigned by Drew SandersPublished on August 12, 2025ContentsEMERGING TECH RESEARCHInnovation Spotlight: Renal DenervationProposed CMS coverage is set to catalyze adoptionPitchBook is a Morningstar company providing the most comprehensive, most accurate, and hard-to-find data for professionals doing business in the private markets.Innovation overviewRenal denervation (RDN) is emerging as a pivotal innovation in the treatment of high blood pressure, also known as hypertension. In July, the US Centers for Medicare & Medicaid Services (CMS) proposed national coverage for RDN for cases of uncontrolled high blood pressure—a major milestone for the field. CMS reimbursement would significantly expand patient access to the treatment and likely lead private insurers to follow suit, positioning RDN for broader adoption across both the US and global healthcare systems.RDN lowers blood pressure by disrupting overactive sympathetic nerves that run alongside the renal arteries, thereby reducing blood flow and lowering blood pressure. This is accomplished via two primary modalities: ultrasound-based renal denervation (uRDN) and radio-frequency-based renal denervation (rfRDN). Two major players lead the RDN market: Medtronic, which offers an rfRDN system, and Recor Medical, which has developed a uRDN platform. Both Medtronic’s Symplicity Spyral system and Recor Medical’s Paradise system received US Food and Drug Administration (FDA) approval in November 2023, though both devices have been available in Europe—and have had the European Conformity (CE) marking—for well over a decade.Our most recent update on RDN was published in our Q4 2023 Medtech Report, which followed the FDA approvals for Medtronic and Recor Medical’s RDN systems. Medtronic’s Symplicity Spyral device had already been CE marked and available in Europe, and it was approved in the US despite failing to meet its primary efficacy endpoint in a study released in November 2022, creating skepticism about whether insurers would ultimately support coverage for the treatment. However, there has been more positive momentum recently, as both Recor Medical and Medtronic were granted transitional pass-through (TPT) payment status, which offers temporary reimbursement to encourage hospital adoption of newly FDA-approved devices. The companies’ TPT payment status began on January 1, 2025, and will run for three years, giving both companies a meaningful first-mover advantage. Other notable players in the space include DeepQure and Boston Scientific, the latter of which acquired VC-backed SoniVie for $600 million in March 2025.