FDA approves trial of renal denervation to treat hypertension

Ablative Solutions has received approval from the FDA for the continuation of testing on its Peregrine System Kit for catheter-based renal denervation with precision delivery of alcohol treatment for hypertension.

The approval gives the company the go-head to conduct its TARGET-BP trial, which will include 100 patients in 20 centers around the globe. The trial of the Peregrine System Kit is targeted for patients with uncontrolled hypertension and uses a specific formula of dehydrated alcohol.

The mix is then infused into the targeted area of nerves around the renal artery using micro-needles within the Peregrine System Infusion Catheter. The alcohol acts as a neurolytic agent to stop the over-signaling of the nerves that causes hypertension in a large majority of patients.

"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,” said Michael Weber, MD. "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."