Verve Medical has announced successful treatment of the first patient in its randomised, double‑blinded US pilot clinical trial using its renal pelvic denervation technology for uncontrolled hypertension.
The RPD pilot trial builds on the results from Verve’s TUSK feasibility trial, which demonstrated an average reduction of approximately 20mmHg 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 company says in a press release.
The first procedure was performed by Michael Borofsky, associate professor and director of endourology fellowship at the University of Minnesota and M Health Fairview (Minneapolis, USA), who specialises 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.
The RPD Pilot trial is enrolling 60 patients across 10 US clinical sites, with participants randomised to receive either RPD therapy or a sham procedure “to ensure rigour and objectivity”.
“Based on prior research done here at the University of Minnesota and other advanced research centres across the country, we are excited to see how the Verve renal pelvic denervation procedure performs,” said 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 offers the potential for a differentiated reduction in blood pressure compared to endovascular denervation technologies.”
Verve’s RPD therapy directly targets overactive renal nerves using radiofrequency (RF) energy delivered into the densely enervated renal pelvis through an outpatient procedure. Unlike 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.
“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. “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, strokes, heart failure, kidney disease and vascular damage,” said David Perry, chief executive officer of Verve Medical. “For patients whose conditions remain uncontrolled despite medication, Verve’s RPD technology offers a targeted, energy‑based approach with the potential to transform care.”
