Ablative Solutions Completes Enrollment in Pivotal Trial of Peregrine Renal Denervation System

April 12, 2023—Ablative Solutions, Inc. announced the completion of patient enrollment in the TARGET BP I study, which is evaluating alcohol-mediated renal denervation with the company’s Peregrine system.

According to the company, the TARGET BP I pivotal clinical trial was designed to evaluate the safety and efficacy of the Peregrine system when used to treat patients with uncontrolled hypertension despite being prescribed two to five antihypertension medications.

Up to 300 patients will be randomized to receive either treatment with the Peregrine system or a sham procedure. Patients and investigators will remain blinded through 6 months of follow-up, which will conclude in Q4 of 2023. Results are expected to be announced in the first half of 2024.

“More than half of patients treated with antihypertension medications do not achieve their target blood pressure,” commented the study’s Coprincipal Investigator David Kandzari, MD, in the company’s press release. “We are excited for the potential of alcohol-mediated renal denervation as a treatment option for this significant unmet medical need.” Dr. Kandzari is Chief, Director of Interventional Cardiology, and Chief Scientific Officer at Piedmont Heart Institute in Atlanta, Georgia.

The Peregrine system kit, which is comprised of an infusion catheter and dehydrated alcohol, is used in a minimally invasive procedure with the goal of deactivating the nerves surrounding the renal arteries, thereby reducing blood pressure. The device is not approved for commercial distribution, and its use is limited to investigation within clinical trials in the United States and Europe, advised the company.