PHOENIX--(BUSINESS WIRE)--Verve Medical, Inc. (Verve) announced today that the Company has received approval from the US Food & Drug Administration (FDA) to initiate its Natural Orifice via renal pelvis denervation (NOVEL- Denervation) Pivotal IDE trial for the treatment of uncontrolled hypertension to lower blood pressure.
The Verve RPD , NOVEL Pivotal trial will be an up to 300 patients, 2/1 randomized, 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.
“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 U.S, 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.”
Hypertension (or High Blood Pressure) results in over 10.7 million deaths per year, making it the leading risk factor for preventable deaths worldwide. Hypertension is a medical condition in which blood pressure in the arteries is persistently elevated. High blood pressure is often the first domino in a “domino effect” leading to devastating consequences such as stroke, heart failure or heart attack, vision loss, and kidney failure. Renal denervation is a simple, 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.
About Verve Medical, Inc.
Verve Medical, headquartered in Phoenix, AZ, is an early-stage medical device company that is committed to developing novel transurethral (natural orifice) renal denervation devices to ameliorate uncontrolled hypertension and associated diseases for the benefit of patients worldwide.
For more information, please visit www.verve-medical.com
Verve Medical and Verve RPD are registered trademarks of Verve Medical, Inc.