In November 2023,
Medtronic “won the big one” in renal denervation
(RDN) when FDA finally approved its Symplicity Spyral RDN System —
schooling us all on the power of persistence
.
Fast forward to 2026, and the space is rapidly evolving with new entrants. But one company is setting itself apart from the crowd by adopting the old real estate mantra of “location, location, location.”
Specifically, Verve Medical is paving the way for renal pelvic denervation (RPD) technology. The Phoenix, AZ-based company recently treated the first patient in its randomized, double-blinded U.S. pilot clinical trial for uncontrolled hypertension. This milestone accelerates the company’s mission to commercialize a novel, targeted, minimally invasive therapy to address the global burden of high blood pressure.
The pilot trial builds on strong results from Verve’s TUSK feasibility trial, which demonstrated an average reduction of 20 mmHg in 24-hour systolic ambulatory 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 renal pelvic denervation 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 U.S. clinical sites, with participants randomized to receive either renal pelvic denervation or a sham procedure.
The first procedure was performed by Michael Borofsky, MD, 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.
Renal pelvic denervation vs. arterial renal denervation
Graphic courtesy of Verve Medical
Verve’s renal pelvic denervation therapy directly targets overactive renal nerves — key drivers of high blood pressure — using radiofrequency energy delivered into the densely innervated 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.
“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, CEO 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.”
Location, location, location — the renal pelvic denervation difference
“Cardiologists and interventional radiologists have a common pathway to treat things within the coronary arteries to the kidneys to even peripheral vascular disease, and so all of this started really with cardiology,” Perry told
MD+DI
. “But if you really study the nerves, they all originate in the renal pelvis.”
So, Perry said Verve thinks it’s in the right location and companies using traditional catheter-based renal denervation procedures are not.
“All of those nerve fibers are very superficial in the renal pelvis, and they are operating on a cellular level to determine how well the kidney is functioning to process fluids and filter fluid out of the body,” Perry said. “And so, for us, it's a really easy pathway to get to, whereas the other guys, they have devices that sometimes are so big that it limits their access to those renal branches to be able to do an ablation.”
With an average reduction of 20 mmHg in 24-hour systolic ambulatory blood pressure, as shown in Verve’s feasibility trial, patients could potentially get off two medications, Perry said.
“That's really significant because the drugs are just, it's not a great life. You've got pelvic pain, you're cloudy, foggy, dizzy, you're tired all the time. If you're a man, it causes [erectile dysfunction]; it's just not great,” Perry said.
In other words, hypertension medication adherence is a tough hill to climb due to all the side effects from the drugs.
“And so, we think location, location, location is the key to our success and the fact that it's a natural orifice, the urinary tract, that urologists can get to very easily.”
And that, he said, leads to an outpatient procedure that's 20 minutes to 30 minutes in length versus an overnight stay, an hour-long procedure with other companies in the renal denervation space.