Verve Medical has received approval from the US Food and Drug Administration (FDA) to initiate its Natural Orifice via renal pelvis denervation (NOVEL-Denervation) pivotal investigational device exemption (IDE) trial for the treatment of uncontrolled hypertension to lower blood pressure.
The Verve RPD, NOVEL pivotal trial will enrol up to 300 patients, and will be a 2:1 randomised, sham-controlled, double-blinded study to determine the safety and efficacy of the Verve RPD minimally invasive, non-vascular renal pelvic denervation system to treat hypertension.
In contrast to other renal denervation approaches in the renal artery, Verve’s method accesses the renal nerves through the natural orifice of the urethra, like a common urology procedure. The Verve RPD system ablates afferent and efferent nerves in the renal pelvis and is likely more effective due to the increased density of innervation in the renal pelvis, where easier access can be obtained versus the traditional arterial renal denervation approach, Verve Medical says in a press release.
“The Verve RPD, NOVEL–Denervation, pivotal trial will be another critical milestone toward making this differentiated therapy available to helping the over one billion uncontrolled hypertension patients worldwide, including 80 million in the USA, who struggle with managing this serious condition,” said Verve president and CEO, David Springer. “This Pivotal trial is designed to provide the basis for approval of the procedure in the US.”
Renal denervation is a minimally invasive procedure designed to treat hypertension. The procedure targets overactive nerves in the kidneys that cause high blood pressure. By delivering energy to these nerves, it decreases their activity and helps to regulate blood pressure.