Pilot Trial Begins for Pelvic Denervation Approach to Hypertension Control

Verve Medical has treated the first patient in its randomized U.S. clinical trial for uncontrolled hypertension (high blood pressure).

The RPD double‑blinded pilot trial builds on the strong results from Verve’s TUSK feasibility study, which demonstrated an average 20 mmHg reduction in systolic blood pressure among treated patients through one year of follow-up.¹ The data highlight the potential of renal pelvic denervation to meaningfully reduce blood pressure in patients with uncontrollable hypertension (despite attempts to reduce it through medications).

“We are excited to build on the momentum from our TUSK trial and are prepared to replicate and expand those results,” Verve Medical Founder/Chief Technology Officer Terry Buelna said. “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.”

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, who specializes in kidney stone disease and advanced endourological procedures. The procedure capitalizes on the relationship between urology and nephrology specialties, combining urologists’ expertise in accessing the renal collecting system with nephrologists’ understanding of blood pressure regulation and its relationship with renal function.

The RPD Pilot trial is enrolling 60 patients at 10 U.S. clinical sites, with participants randomized to receive either RPD therapy or a sham procedure to ensure rigor and objectivity.

“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 of the 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 offers the potential for a differentiated reduction in blood pressure compared to endovascular denervation technologies.”

Verve’s RPD therapy directly targets overactive renal nerves—key high blood pressure drivers—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 frequently used by urologists. The company’s solution enables clinicians to potentially perform these procedures in ambulatory care settings. 

“Hypertension remains one of the most pervasive and dangerous global health challenges, contributing to heart attacks, strokes, heart failure, kidney disease, and vascular damage,” Verve Medical CEO David Perry stated. “For patients whose conditions remain uncontrolled despite medication, Verve’s RPD technology offers a targeted, energy‑based approach with the potential to transform care.”

Verve Medical is a clinical‑stage medical device company developing renal pelvic denervation (RPD) devices to treat uncontrolled hypertension and related diseases. The company’s patented platform is designed to ablate both afferent and efferent nerves involved in blood pressure regulation, offering a differentiated approach to device-based hypertension treatment.

Reference
¹ Hering D, et al. Transurethral Renal Pelvic Denervation: A Feasibility Trial in Patients with Uncontrolled Hypertension. Hypertension. 2022;79:2787–2795. DOI: 10.1161/HYPERTENSIONAHA.122.20048.