Ablative Solutions, Inc. Announces Primary Endpoint Met in the TARGET BP I Pivotal Trial of the Peregrine System™ Kit for Patients with Uncontrolled Hypertension
19 Dec 2023
Clinical ResultAHAPhase 1
WAKEFIELD, Mass., Dec. 19, 2023 /PRNewswire/ -- Ablative Solutions, Inc., today announced that the TARGET BP I Pivotal Trial evaluating alcohol-mediated renal denervation with the Peregrine System™ Kit met its primary endpoint, showing a statistically significant difference in 24-hour Ambulatory Blood Pressure between treatment and sham procedure at 3 months.
The TARGET BP I trial evaluated the safety and efficacy of the Peregrine System Kit to treat patients with uncontrolled hypertension while taking anti-hypertensive medications. The Peregrine System Kit, comprised of a patented infusion catheter and dehydrated alcohol, was used during a minimally invasive procedure to ablate the sympathetic nerves surrounding the renal (kidney) arteries to reduce blood pressure.
"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", stated David Kandzari, M.D., co-principal investigator, chief of Piedmont Heart Institute and chief scientific officer for Piedmont Healthcare. "We look forward to sharing these data in the coming months".
The TARGET BP I Trial enrolled patients with uncontrolled hypertension despite being prescribed 2 – 5 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. More information about the TARGET BP I Trial is available at https://clinicaltrials.gov/ct2/show/NCT02910414.
"We are excited to have achieved this significant milestone in the Company's history", stated Kate Rumrill, President and CEO of Ablative Solutions, Inc., "We are grateful to our physician advisors, study investigators and coordinators, and company employees for their contributions in the delivery of these important data."
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.
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 Kit is currently being investigated as a treatment for uncontrolled hypertension. For more information visit www.ablativesolutions.com.
CONTACT: Kate Rumrill, [email protected]
SOURCE Ablative Solutions, Inc.
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