Verve Medical Initiates U.S. Pilot Trial for Novel Renal Denervation Therapy Following Promising TUSK Results
Key Insights
Verve Medical (search) has treated the first patient in its randomized, double-blinded U.S. pilot trial testing renal pelvic denervation (RPD) technology for uncontrolled hypertension (search).
The trial builds on promising TUSK feasibility results showing approximately 20 mmHg reduction in systolic blood pressure among treated patients through one year of follow-up.
The RPD therapy uses radiofrequency energy delivered through the urinary tract to target renal nerves (search), offering a differentiated approach compared to traditional catheter-based renal denervation methods.
Verve Medical (search) has successfully treated the first patient in its randomized, double-blinded U.S. pilot clinical trial for uncontrolled hypertension (search), marking a significant milestone in the development of its novel renal pelvic denervation (RPD) technology. The clinical-stage medical device company announced this achievement on March 11, 2026, as it advances toward commercializing a minimally invasive therapy to address the global burden of high blood pressure (search).
Building on TUSK Trial Success
The RPD Pilot trial builds on strong results from Verve's TUSK feasibility trial, which demonstrated an average reduction of approximately 20 mmHg in systolic blood pressure among treated patients through one year of follow-up. These findings highlighted the potential of renal pelvic denervation to meaningfully reduce blood pressure in patients whose hypertension remains uncontrolled despite taking multiple medications.
The first procedure was performed by Dr. Michael Borofsky, associate professor and director of endourology fellowship at the University of Minnesota and M Health Fairview (search), who specializes in kidney stone disease and advanced endourological procedures. The procedure takes advantage of the relationship between urology and nephrology specialties, combining urologists' expertise in accessing the renal collecting system with nephrologists' deep understanding of blood pressure regulation and its relationship with renal function.
Trial Design and Methodology
The RPD Pilot trial is enrolling 60 patients across 10 U.S. clinical sites, with participants randomized to receive either RPD therapy or a sham procedure to ensure rigor and objectivity. This design allows for proper evaluation of the therapy's efficacy while maintaining scientific standards.
"Based on prior research done here at the University of Minnesota and other advanced research centers across the country, we are excited to see how the Verve renal pelvic denervation procedure performs," said Dr. John Osborn, professor, Department of Surgery, at the University of Minnesota Medical School, chief - Division of Autonomic Neuromodulation and director of the Minnesota Consortium for Autonomic Neuromodulation. "Theoretically, the proposed ability to target a greater volume of afferent nerves (search) offers the potential for a differentiated reduction in blood pressure compared to endovascular denervation technologies."
Innovative Technology Approach
Verve's RPD therapy directly targets overactive renal nerves (search) – key drivers of high blood pressure (search) – using radiofrequency (RF) energy delivered into the densely enervated renal pelvis through an outpatient procedure. Unlike traditional catheter-based renal denervation approaches that access the renal arteries from within the bloodstream, Verve's technology leverages the patient's natural urinary tract, which is used frequently by urologists, creating the potential for procedures to be performed in ambulatory care settings.
The company's patented platform is designed to ablate both afferent and efferent nerves (search) involved in blood pressure regulation, offering a differentiated approach to device-based hypertension treatment.
Clinical Significance and Market Impact
"We are excited to build on the momentum from our TUSK trial and are prepared to replicate and expand those results," said Terry Buelna, chief technology officer and founder of Verve Medical (search). "Our goal is to redefine what's possible in both office and ambulatory blood pressure reduction and bring patients a new era of hypertension management."
"Hypertension remains one of the most pervasive and dangerous global health challenges, contributing to heart attacks (search), strokes (search), heart failure (search), kidney disease (search) and vascular damage," said David Perry, chief executive officer of Verve Medical (search). "For patients whose conditions remain uncontrolled despite medication, Verve's RPD technology offers a targeted, energy-based approach with the potential to transform care."
The company is currently a clinical-stage organization pending FDA approval for its innovative renal pelvic denervation technology.