Verve Medical’s Data Published From Feasibility Trial for Transurethral Renal Pelvic Denervation for Uncontrolled Hypertension

November 16, 2022—Verve Medical, Inc. announced results from a feasibility trial evaluating ablation therapy with the company’s RPD renal pelvic denervation system. The findings included a therapeutically significant blood pressure (BP) reduction for 100% of treated patients with uncontrolled hypertension.

The trial demonstrated the efficacy and safety of Verve’s minimally invasive nonvascular RPD system. In contrast to other renal denervation approaches in the renal artery, the Verve device accesses the renal nerves through the natural orifice of the urethra, similar to common urology procedures.

The results of the Verve study were published by Dagmara Hering, MD, et al in Hypertension (2022;79:2787-2795).

According to the company, 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. No serious adverse events were observed during the study. Additionally, renal function was not adversely affected as evidenced by the significant reduction in serum creatinine of 0.08 mg/dL (9% reduction) and significant increase in estimated glomerular filtration rate of 7.2 mL/min/1.73m² (9% increase) at the 2-month endpoint.

The Verve study was an open-label, single-arm feasibility study that enrolled 18 patients (mean age, 56 years) with uncontrolled hypertension despite antihypertensive drug therapy. The primary effectiveness endpoint was the change in ambulatory daytime systolic BP 2 months following Verve’s novel renal pelvic denervation. The patients were taking an average of 2.7 antihypertensive drugs daily. All 18 patients responded to the treatment with a drop in ambulatory systolic BP.

The clinical protocol specified that patients were to be followed for 12 months, with safety and efficacy measures monitored at routine intervals. The durability of the Verve treatment was significant at all endpoints. Results of the 12-month data will be published in the near future, stated the company.

Professor Michael Weber, MD, a cardiologist and senior investigator of the study, commented in the company’s press release, “We are pleased that we were able to complete this feasibility study of renal denervation for people with uncontrolled hypertension. The efficacy of this simple procedure is now established, and we did not identify any safety concerns during the study. This sets the stage for a large, randomized controlled trial designed to provide the basis for approval of the procedure in the United States.”

Nephrologist Robert Provenzano, MD, added, “Renal denervation via the renal pelvis offers a novel and potentially safer approach to patients with resistant hypertension. Importantly, ablation of both afferent and efferent nerves in the renal pelvis 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. Furthermore, the Verve RPD system appears more effective because nerves in the renal pelvis are within 1 mm from the Verve RPD electrodes whereas the nerves can be up to 7 mm via the arterial approach. The Verve RPD Phoenix system offers an exciting opportunity to improve the lives of patients with resistant hypertension.”

Drs. Hering, Weber, and Provenzano are advisors to Verve Medical.