Ablative application for Peregrine System Kit gains FDA acceptance

Ablative Solutions' Investigational New Drug application for the Peregrine System Kit -- a catheter-based renal denervation that targets the delivery of alcohol to treat uncontrolled hypertension -- has been accepted by the U.S. Food and Drug Administration.
Next up for Ablative is the clinical trial TARGET-BP I, which will enroll approximately 100 patients around the world to assess the device’s combination therapy to treat persistent hypertension. This involves dehydrated alcohol that is infused into the area around the renal artery.
"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," Michael Weber, one of the study’s principal investigators, said. "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."
Weber said the carefully considered trial protocol and the innovative catheter-based therapeutic delivery being studied in TARGET-BP I will attract considerable attention among experts and practitioners who work in the field of hypertension.