Ablative Solutions, Inc., a company pioneering new approaches to the treatment of hypertension, today announced the completion of patient enrollment in the TARGET BP I Pivotal Study evaluating alcohol-mediated renal denervation with the Peregrine System.
| WAKEFIELD, Mass., April 12, 2023 /PRNewswire/ -- Ablative Solutions Inc, a company pioneering new approaches to the treatment of hypertension, today announced the completion of patient enrollment in the TARGET BP I Pivotal Study evaluating alcohol-mediated renal denervation with the Peregrine System.
“We are pleased to announce this significant milestone”, stated Kate Rumrill, President and CEO of Ablative Solutions, Inc., “We want to formally thank our physician advisors, study investigators, and study coordinators for their leadership and contributions to this landmark study.” As part of the TARGET BP clinical trials program, the TARGET BP I pivotal clinical study was designed to evaluate the safety and efficacy of the Peregrine System when used to treat patients with uncontrolled hypertension despite taking anti-hypertensive medications. The Peregrine System Kit used in this trial is comprised of a patented infusion catheter and dehydrated alcohol, it is used in a minimally invasive procedure with the goal of deactivating the nerves surrounding the renal (kidney) arteries and thereby reducing blood pressure. The TARGET BP I Study enrolled patients with uncontrolled hypertension despite being prescribed 2 – 5 antihypertension medications. Up to 300 patients will be randomized to either receive treatment with the Peregrine System or a sham procedure. Patients and investigators will remain blinded through 6 months of follow-up. These follow-up visits will conclude in Q4 of 2023 and results are expected to be announced in the first half of 2024. “More than half of patients treated with anti-hypertension medications do not achieve their target blood pressure. We are excited for the potential of alcohol-mediated renal denervation as a treatment option for this significant unmet medical need”, stated David Kandzari, M.D., co-principal investigator of the TARGET BP I trial, Chief, Director of Interventional Cardiology and Chief Scientific Officer at Piedmont Heart Institute. About the Peregrine System The Peregrine System Kit is comprised of two components, the Peregrine System Infusion Catheter and dehydrated alcohol. The 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. The Company has now completed enrollment of patients in the TARGET BP I pivotal trial to evaluate safety and efficacy in the treatment of patients with uncontrolled hypertension despite taking anti-hypertensive medications. More information about the TARGET BP I Trial can be found at https://clinicaltrials.gov/ct2/show/NCT02910414. About Ablative Solutions Ablative Solutions, Inc., based in Wakefield, MA, was founded in 2011 with a vision of reinventing renal denervation to improve cardiovascular health. Ablative Solutions’ approach targets the overactive sympathetic nervous system, which may play a role in hypertension, heart failure, kidney disease, metabolic syndrome, and sleep apnea. The Peregrine System is currently being investigated as a treatment for uncontrolled hypertension. For more information visit www.ablativesolutions.com. CONTACT:
SOURCE Ablative Solutions, Inc. |
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