US-based Verve Medical has reported the treatment of the first patient in its pilot trial for uncontrolled hypertension with a renal pelvic denervation (RPD) device.
The double-blinded, randomised trial follows positive outcomes from the TUSK feasibility trial, which showed an average systolic blood pressure reduction of about 20mmHg in treated patients after one year.
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The initial procedure was conducted by the University of Minnesota and M Health Fairview associate professor and endourology fellowship director, Dr Michael Borofsky.
The procedure utilises expertise from both urology and nephrology, linking renal system access with an understanding of blood pressure regulation.
The RPD pilot trial plans to include 60 participants at ten US clinical sites, who will be randomised to receive either RPD therapy or a sham procedure, maintaining scientific rigour and objectivity.
Verve Medical’s RPD therapy targets overactive renal nerves, which are significant contributors to high blood pressure. The technique uses radiofrequency energy delivered directly to the renal pelvis via a minimally invasive outpatient approach, employing the natural urinary tract.
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By GlobalDataThis differs from traditional catheter-based renal denervation therapies that access the arteries via the bloodstream. Using the urinary tract may allow such interventions to take place in ambulatory care facilities.
Verve Medical’s chief technology officer and founder Terry Buelna said: “We are excited to build on the momentum from our TUSK trial and are prepared to replicate and expand those results.
“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.”
Verve Medical CEO David Perry said: “Hypertension remains one of the most pervasive and dangerous global health challenges, contributing to heart attacks, strokes, heart failure, kidney disease and vascular damage.
“For patients whose conditions remain uncontrolled despite medication, Verve’s RPD technology offers a targeted, energy-based approach with the potential to transform care.”
