Post-market trial of Peregrine System shows efficacy in resistant hypertension.- Ablative Solutions

Ablative Solutions announced 12-month results from the Peregrine Post-Market Clinical Trial, which were presented during a symposium at the 2019 European Society of Cardiology (ESC) Congress in Paris. The Peregrine Post-Market Study is a European multicenter open-label trial that evaluated additional safety and performance of the CE-marked Peregrine System Infusion Catheter using a neurolytic agent (dehydrated alcohol) delivered into the space outside of the renal (kidney) arteries in 45 patients with systemic hypertension. Patients included in the study were taking at least three anti-hypertensive medications.

A statistically significant reduction of 24-hour mean systolic ambulatory blood pressure measurement (ABPM) at six months, the study's primary efficacy outcome, was sustained at 12 months, providing evidence of consistent blood pressure-lowering effect. Twelve (12) month results also showed a reduction of mean systolic 24-hour ambulatory blood pressure of 10 mmHg (� 17 mmHg, p=0.001) and a reduction in systolic office blood pressure of 20 mmHg (� 23 mmHg, p=0.001). No patients had major adverse events.

The investigational Peregrine Kit, which includes the Peregrine System Infusion Catheter (Peregrine Catheter) and Ablative Solutions dehydrated alcohol, is currently being investigated in the TARGET BP clinical program which comprises two clinical trials. Data from the TARGET BP I and TARGET BP OFF-MED trials will be used to continue to advance the understanding of renal denervation.