Verve Medical, Inc. (“Verve”) today announced the detailed results from a feasibility trial evaluating a novel ablation therapy that achieved therapeutically significant blood pressure (“BP”) reduction for 100% of treated patients with uncontrolled hypertension.
The Verve trial demonstrated the efficacy and safety of this minimally invasive, non-vascular renal pelvic denervation. 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, similar to common urology procedures.
The results of the Verve study were published last week in the American Heart Association’s (“AHA”) Hypertension journal. Hypertension is the leading risk factor for preventable deaths worldwide. See link to AHA publication below: (www.ahajournals.org/doi/abs/10.1161/HYPERTENSIONAHA.122.20048).
Verve’s novel 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, and 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 (eGFR) of 7.2 mL/min/1.73m2 (9% increase) at the two-month endpoint.
“The success of this feasibility study is an important step toward making this novel therapy available to helping the over one billion hypertension patients worldwide, including 116 million in the U.S, who struggle with managing this serious condition,” said Verve President and CEO, David Springer. “We believe this study validates the original premise of our patented non-vascular renal denervation approach and look forward to initiating our sham-controlled pivotal trial in early 2023.”
The Verve study was an open-label, single-arm feasibility study that enrolled patients with uncontrolled hypertension despite antihypertensive drug therapy. The primary effectiveness endpoint was the change in ambulatory daytime systolic BP two months following Verve’s novel renal pelvic denervation. The 18 patients (mean age 56 years) enrolled 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, and results of the 12-month data will be published in the near future.
“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,” said cardiologist and Verve advisor, Professor Michael Weber, MD, FAPC, FACC, FAHA. “This sets the stage for a large randomized controlled trial designed to provide the basis for approval of the procedure in the US.”
“Renal denervation via the renal pelvis offers a novel and potentially safer approach to patients with resistant hypertension,” said nephrologist and Verve advisor Robert Provenzano, MD, FACP, FASN, FNKF. “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 1mm from the Verve RPD™ electrodes whereas the nerves can be up to 7mm via the arterial approach. The Verve RPD™ Phoenix system offers an exciting opportunity to improve the lives of patients with resistant hypertension.”
