Verve Medical’s Renal Pelvic Denervation System Receives IDE Approval for Pivotal Trial

July 11, 2023—Verve Medical, Inc., an early-stage medical device company headquartered in Phoenix, Arizona, announced that it has received approval from the FDA to initiate its NOVEL-Denervation pivotal investigational device exemption (IDE) trial of the company’s minimally invasive, nonvascular transurethral Verve renal pelvic denervation (RPD) system for the treatment of uncontrolled hypertension.

According to the company, the NOVEL—“natural orifice via renal pelvis denervation”—pivotal IDE trial will be a sham-controlled, double-blinded study composed of up to 300 patients randomized 2:1. The trial is designed to determine the safety and efficacy of the Verve RPD system to treat hypertension.

Verve Medical stated that its 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. The company stated that this approach may be more effective because of the increased density of innervation in the renal pelvis, where easier access can be obtained than with renal denervation approaches via the renal artery.

In November 2022, the company announced that the results of the Verve feasibility study were published by Dagmara Hering, MD, et al in Hypertension (2022;79:2787-2795). The feasibility study findings included a therapeutically significant blood pressure (BP) reduction for 100% of treated patients with uncontrolled hypertension. Verve’s modality reduced mean 24-hour systolic BP by 20.3 mm Hg and systolic BP as measured in a doctor’s office setting (utilizing the SPRINT method) by 22.4 mm Hg at the 2-month primary endpoint.

The feasibility study of the Verve RPD system showed durability to at least 1 year in patients with uncontrolled hypertension, noted the company in the current press release.