Yet another renal denervation trial will soon be underway after the US Food and Drug Administration (FDA) approved a pivotal trial by US-based Verve Medical.
The investigational device exemption (IDE) for the company comes after a recent approval for Metavention’s clinical study.
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Verve Medical’s trial will test its renal pelvis denervation system in up to 300 patients to evaluate the safety and efficacy of the procedure as a possible treatment for hypertension. The company says that its system, unlike other renal denervation systems that use the renal artery, accesses renal nerves through the urethra. Entering the urethra via its natural orifice, Verve’s system ablates nerves in the renal pelvis. The company goes on to say that this is more effective, due to the higher density and greater accessibility of nerves in the renal pelvis.
Verve’s 2:1 randomised, double-blinded, sham-controlled study comes in a key year for renal denervation. Medtronic and ReCor are both awaiting a verdict from the FDA in August for their systems. Clinical studies using renal denervation to treat hypertension have produced mixed results. While some have shown the procedure’s ability to reduce hypertension, Medtronic’s study did not meet its primary endpoint. The sector will eagerly await results from Verve’s system, which uses a different approach.
Verve Medical CEO and president David Springer said: “The Verve RPD, NOVEL – Denervation, Pivotal trial will be another critical milestone toward making this differentiated therapy available to help the over one billion uncontrolled hypertension patients worldwide, including 80 million in the US, who struggle with managing this serious condition.
“This Pivotal trial is designed to provide the basis for approval of the procedure in the US.”
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