Ablative Solutions’ Peregrine RDN System Meets Primary Endpoint in TARGET BP I Pivotal Trial

December 19, 2023—Ablative Solutions, Inc. announced that the TARGET BP I pivotal trial evaluating alcohol-mediated renal denervation with the company’s Peregrine system kit met its primary endpoint. The trial showed a statistically significant difference in 24-hour ambulatory blood pressure between treatment and sham procedures at 3 months.

According to the company, the TARGET BP I trial evaluated the safety and efficacy of the Peregrine system kit to treat patients with uncontrolled hypertension while taking antihypertensive medications.

The TARGET BP I trial enrolled patients with uncontrolled hypertension despite being prescribed two to five antihypertension medications. A total of 301 patients were randomized to either receive treatment with the Peregrine system kit or sham procedure. The study remained blinded through 6 months follow-up.

The Peregrine system kit was used during a minimally invasive procedure to ablate the sympathetic nerves surrounding the renal arteries to reduce blood pressure. The kit is composed of the company’s infusion catheter and dehydrated alcohol.

“We are happy to announce the completion of the primary analysis of this landmark trial and are excited for the potential of alcohol-mediated renal denervation as a treatment option addressing the widespread public health issue of uncontrolled hypertension,” commented Coprincipal Investigator David Kandzari, MD, in the company’s press release. “We look forward to sharing these data in the coming months.” Dr. Kandzari is Chief of Piedmont Heart Institute and Chief Scientific Officer for Piedmont Healthcare in Atlanta, Georgia.

Ablative Solutions’ Peregrine system kit for renal denervation 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.