Hypertension Center

EMBRACE to Study Medtronic’s Symplicity Spyral RDN System With Staged PCI

March 31, 2026—Medtronic announced it is supporting the investigator-initiated EMBRACE trial of the company’s Symplicity Spyral renal denervation (RDN).

Verve’s United States Pilot Trial of Renal Pelvic Denervation Therapy Enrolls First Patient

March 11, 2026—Verve Medical, a developer of noninvasive renal pelvic denervation (RPD) technology, announced the treatment of the first patient in its randomized, double-blinded United States pilot clinical trial for the treatment of uncontrolled hypertension.

Medtronic Symplicity Spyral RDN Studied in Pooled Analyses from SPYRAL HTN Program

March 11, 2026—New analyses from the SPYRAL HTN clinical study program presented at CRT 2026 reported long-term outcomes with the Symplicity Spyral radiofrequency (RF) renal denervation (RDN) system (Medtronic), including a pooled 3-year efficacy analysis, a study of hypertensive urgencies, and the design of the SPYRAL CARE real-world study.

Otsuka’s Paradise uRDN System Launched in Japan With National Health Insurance Coverage


March 2, 2026—Otsuka Medical Devices Co., Ltd. and Otsuka Pharmaceutical Co., Ltd., announced the commercial launch of the Paradise ultrasound renal denervation (uRDN) system.

Medtronic Secures Japan Reimbursement for Spyral RDN

February 19, 2026—Medtronic plc announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted reimbursement approval for the Symplicity Spyral renal denervation (RDN) system (Medtronic) for the treatment of resistant hypertension.

Gore Viatorr TIPS Endoprosthesis Expanded Diameter Range Gains CE Mark Approval

January 30, 2026—Gore & Associates announced European CE Mark approval of a 6- to 10-mm diameter range for the Gore Viatorr TIPS—transjugular intrahepatic portosystemic shunt—endoprosthesis with controlled expansion.

Neurotronic’s Neuviant Multiorgan Denervation Studied to Treat Type 2 Diabetes and Hypertension

November 17, 2025—Neurotronic, Inc. announced the first clinical outcomes of the NECTAR III and NECTAR IV trials evaluating the company’s Neuviant multiorgan denervation (MDN) system in patients with both type 2 diabetes mellitus (T2DM) and hypertension (HTN).

CMS Finalizes National Coverage Determination for Renal Denervation Systems

October 29, 2025—The Centers for Medicare & Medicaid Services (CMS) has released the final National Coverage Determination (NCD) on renal denervation (RDN).

New Diameter Range Approved for Gore’s Viatorr TIPS Endoprosthesis With Controlled Expansion

October 27, 2025—Gore & Associates announced FDA approval of a 6- to 10-mm diameter range for the Viatorr TIPS—transjugular intrahepatic portosystemic shunt—endoprosthesis with controlled expansion.

Long-Term SPYRAL HTN-ON MED Data Presented for Medtronic’s Symplicity Spyral RDN System

October 26, 2025—Medtronic announced that long-term results from its final report of the SPYRAL HTN-ON MED trial showed that patients treated with the company’s radiofrequency-based Symplicity Spyral renal denervation (RDN) procedure experienced significantly greater reductions in blood pressure compared to sham patients through 3 years.

Pulnovo’s PADN System Receives Two IDE Approvals for Pulmonary Hypertension

September 12, 2025—Pulnovo Medical, a Shanghai, China-based developer of medical devices for pulmonary hypertension (PH) and heart failure, announced that its pulmonary artery denervation (PADN) catheter and generator received two investigational device exemption (IDE) approvals from the FDA.

Medtronic’s Symplicity Spyral Renal Denervation System Approved in Japan

September 2, 2025—Medtronic announced that its Symplicity Spyral renal denervation (RDN) system has been approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of resistant hypertension.

Otsuka Medical Devices Announces Japan Approval of Paradise uRDN System

August 25, 2025—Otsuka Medical Devices Co., Ltd. announced that the Paradise ultrasound renal denervation (uRDN) system has received manufacturing and marketing approval in Japan for the treatment of resistant hypertension.

Medtronic’s SPYRAL GEMINI Multiorgan Denervation Study Begins Enrollment

July 7, 2025—Medtronic announced that the first patient has been treated in its SPYRAL GEMINI global pilot study, which will investigate the safety and potential efficacy of multiorgan denervation (MDN) in patients with uncontrolled hypertension (HTN).

Medtronic’s GSR-DEFINE Study of Symplicity Spyral RDN System Enrolls First United States Patient

June 11, 2025—Medtronic announced the treatment of the first patient in the United States in the GSR-DEFINE clinical trial.

ACC and BIDMC Smith Center Collaborate on Renal Denervation Registry

June 10, 2025—The American College of Cardiology (ACC) reported that the Richard A. and Susan F. Smith Center for Outcomes Research at Beth Israel Deaconess Medical Center (BIDMC) in Boston, Massachusetts, and ACC are collaborating on a renal denervation (RDN) module that leverages the Smith Center’s RDN Registry and the ACC CathPCI Registry.

Gradient’s Pulmonary Artery Denervation System Receives FDA Breakthrough Designation

May 19, 2025—Gradient Denervation Technologies, which is based in Paris, France, announced that the company’s pulmonary artery denervation (PADN) system has received FDA Breakthrough Device designation.

Route 92’s Monopoint Venous Sinus System Studied to Treat Idiopathic Intracranial Hypertension

March 19, 2025—Route 92 Medical, Inc. announced the results of a multicenter study evaluating the utility of the company’s Monopoint venous sinus system in neurovascular interventional procedures to treat idiopathic intracranial hypertension.

Boston Scientific to Acquire SoniVie

March 3, 2025—Boston Scientific Corporation announced it has entered into a definitive agreement to acquire SoniVie Ltd., a privately held medical device company that has developed the Tivus intravascular ultrasound system for denervation of renal nerves surrounding blood vessels to treat a variety of hypertensive disorders.

CMS Initiates NCA on Renal Denervation for Uncontrolled Hypertension

January 13, 2025—Medtronic and Recor Medical, Inc. separately announced that the Centers for Medicare & Medicaid Services (CMS) is opening a national coverage analysis (NCA; CAG-00470N) on renal denervation (RDN) for uncontrolled hypertension.