Verve Medical Announces Results of Feasibility Trial for Transurethral Renal Pelvic Denervation for Uncontrolled Hypertension

Study of the Verve RPD™ Renal Pelvic Denervation System Shows 20.3 mm Hg Reduction in Blood Pressure in Patients with Uncontrolled Hypertension

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.”

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The Evolut ™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access
The study was an analysis of AstraZeneca’s Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF). The patient data from the trial was processed with Brainomix’s e-Lung tool. The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
“Since the algorithm for matching patients with donors is changing across for all organs, this was a prime time to better understand whether transplant team decisions to accept a donated organ varied by patient race and gender,” she said. “We wanted to understand how the process of receiving a transplant after listing varied by race and gender, and the combination of the two, so that steps can be taken to make that process more equitable," said Khadijah Breathett, MD.
The Mount Sinai study found that primary care physicians’ approach reflects a dearth of evidence-based guidance for lung cancer screening shared decision-making in patients with complex comorbidities
This is the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.

By using this website you agree to accept Medical Device News Magazine Privacy Policy

Exit mobile version