Ablative Solutions said today that the FDA approved a Phase II trial of its chemical denervation system for hypertension under its investigational new drug application.
The trial, called Target-BP I, will evaluate the efficacy of Ablative’s Peregrine infusion ablation system, which uses ethanol to interrupt signals from sympathetic nerves in the renal artery to control hypertension.
Ablative Solutions said the 100-patient, randomized, double-blind, sham-controlled trial is slated to enroll patients at 20 global sites.
The Peregrine system is minimally invasive, using a small access site in the femoral artery to snake a catheter to the renal artery. Microneedles deliver dehydrated alcohol to the nerve tissue, which forms an envelope around the artery and interrupts signals from sympathetic nerves. Standard renal denervation uses radiofrequency to silence sympathetic nerves, which can be extremely painful; Ablative’s system causes minimal discomfort to patients, according to the company.
The drug-device combo won the CE Mark in May 2015 and has general 510(k) clearance in the U.S.
“The mechanism for the use of targeted chemical denervation makes sense to me because I believe it has the potential to effectively reduce the over-signaling of the renal nerves that can contribute to hypertension,” co-principal investigator Dr. Michael Weber said in prepared remarks. “The company has received approval from the FDA to conduct a trial that studies the safety and efficacy of an intervention designed to address challenges that physicians face in managing patients with hypertension. The carefully considered trial protocol and the innovative catheter-based therapeutic delivery being studied in Target-BP I will attract considerable attention among the experts and practitioners who work in the field of hypertension.”
“The field has learned a lot through early experiences using first-generation products for renal denervation. There is agreement that improving our control of blood pressure is paramount, and we think that interrupting the sympathetic nerves through renal denervation may indeed prove to be clinically beneficial,” added co-principal investigator Dr. David Kandzari. “I’m excited about chemical denervation because I believe it builds upon the learning that has taken place, addressing issues with its approach of using alcohol as a neurolytic agent to directly target these nerves.”
The renal denervation market is still reeling from Medtronic’s (NYSE:MDT) failed Symplicity-3 trial in 2014, which prompted some companies to pull the plug on their own renal denervation research. Covidien shut down its OneShot renal denervation program despite ongoing clinical trials and approval for use in Europe; St. Jude Medical called off its Enlightn IV trial but did not altogether abandon the RDN market.
After the failed trial, a Medtronic-sponsored examination of the data suggested that there were confounding variables, such as variations in procedures and changing drug regimens, which may have led to the surprising trial results.
