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.

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.

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).

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.

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.

Hemodynamic Effects of AVIM Therapy for Hypertension Analyzed in Pressure-Volume Loop Study

August 26, 2025—Orchestra BioMed Holdings, Inc. announced the publication of data from a pressure-volume (PV) loop study demonstrating favorable hemodynamic effects of atrioventricular interval modulation (AVIM) therapy in pacemaker-indicated patients with uncontrolled 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.

Pulnovo Medical Names Dr. Francis Duhay as Global CMO

August 25, 2025—Pulnovo Medical, a developer of mechanism-driven therapies for pulmonary hypertension and heart failure, announced the appointment of Francis Duhay, MD, as Global Chief Medical Officer. Dr.

Renal Denervation Included in ACC/AHA 2025 High Blood Pressure Guideline

August 15, 2025—The American College of Cardiology (ACC) and the American Heart Association (AHA) separately announced publication of the 2025 multisociety guideline for the prevention, detection, evaluation, and management of high blood pressure in adults.

CMS Seeks Comments on Proposed Decision Memo for RDN to Treat Hypertension

July 10, 2025—The Centers for Medicare & Medicaid Services (CMS) issued a proposed decision memo for its National Coverage Analysis (NCA) of renal denervation (RDN)—including radiofrequency (rfRDN) and ultrasound (uRDN) treatments—for uncontrolled hypertension under Coverage with Evidence Development (CED).

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).

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.

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.

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.

Pulnovo’s PADN Catheter Receives CE Mark Clearance Under EU MDR

April 16, 2025—Pulnovo Medical, a China-based developer of medical devices for pulmonary hypertension (PH) and heart failure, announced that its pulmonary artery denervation (PADN) catheter for treating PH has received CE Mark clearance under the European Union Medical Device Regulation.

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.

Pulnovo Medical Closes Series C Financing to Advance Trials of PADN Technology

March 2, 2025—Pulnovo Medical announced the closing of approximately $100 million Series C financing.