FDA Approves IDE Trial of Verve Medical’s Treatment for Uncontrolled Hypertension

Verve Medical Inc. has received U.S. Food and Drug Administration (FDA) authorization to begin its hypertension treatment study.
 
The Natural Orifice via renal pelvis denervation (NOVEL- Denervation) IDE (investigational device exemption) pivotal trial is a two to one 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 uncontrolled hypertension. Up to 300 patients will be enrolled in the study,

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, according to the company.
 
“The Verve RPD, NOVEL – Denervation, Pivotal trial will be another milestone toward making this differentiated therapy available to helping the over 1 billion uncontrolled hypertension patients worldwide, including 80 million in the U.S, who struggle with managing this serious condition,” Verve President/CEO David Springer said. “This Pivotal trial is designed to provide the basis for approval of the procedure in the U.S.”
 
Hypertension (or high blood pressure) results in more than 10.7 million deaths annually, 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 such consequences 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.
 
Headquartered in Phoenix, Ariz., Verve Medical is an early-stage medical device company developing transurethral (natural orifice) renal denervation devices to ameliorate uncontrolled hypertension and associated diseases.