February 20, 2020
Six-Month Data Published From Ablative Solutions’ Peregrine Postmarket Study
February 20, 2020—Ablative Solutions, Inc. announced that 6-month results from the Peregrine postmarket study were published by Professor Felix Mahfoud, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2020;13:471–484).
The company stated that the data demonstrate the safety and efficacy of the company’s CE Mark–approved Peregrine system infusion catheter for the renal denervation treatment of hypertension. The Peregrine catheter with Ablative Solutions’ dehydrated alcohol is a component of the investigational Peregrine Kit, which is currently being investigated in the TARGET BP clinical program and comprises two clinical trials: TARGET BP I and TARGET BP OFF-MED. These trials will be used to continue to advance the understanding of renal denervation.
The Peregrine postmarket study is a European, multicenter, open-label trial evaluating additional safety and performance of the Peregrine device, which uses a neurolytic agent (dehydrated alcohol) delivered into the space outside of the renal arteries in 45 patients with systemic hypertension. Patients included in the study were taking at least three antihypertensive medications.
Ablative Solutions reported that at 6 months, mean 24-hour ambulatory systolic blood pressure was reduced by 11 mm Hg, and diastolic blood pressure was reduced by 7 mm Hg. Medication adherence was monitored and remained stable throughout the study.
The primary safety endpoint (defined as absence of periprocedural major vascular complications, major bleeding, acute kidney injury, or death within 1 month) was met in 96% of patients (95% confidence interval, 85%–99%).
Prof. Mahfoud commented in the company’s announcement, “Results from this trial show that the renal denervation procedure using the Peregrine catheter and alcohol as a neurolytic agent may be safe and effective for lowering blood pressure in patients with poorly controlled hypertension on medications. The publication of these data further proves the potential value of the system for both physicians and patients. We look forward to further studying the investigational product in the randomized, sham-controlled TARGET BP clinical program.” Prof. Mahfoud is from Saarland University Hospital in Homburg, Germany.
The company noted that an editorial in JACC: Cardiovascular Interventions by Deepak L. Bhatt, MD, and Arjun Majithia, MD, discussed the evolution of renal artery denervation (2020;13:485–487). Drs. Bhatt and Majitha stated, “[A]lthough the Peregrine system will clearly need to be tested in a randomized, blinded, sham-controlled clinical trial environment, the study investigators should be complimented for using rigorous, contemporary methods including objective adherence measurements (urine toxicology analysis) and appropriate, clinically relevant endpoints (ambulatory blood pressure).”
Additionally, the company advised that 12-month results from the Peregrine postmarket clinical trial were presented in a symposium at the 2019 European Society of Cardiology congress, held August 31 to September 3 in Paris, France. The data showed that the statistically significant reduction of 24-hour mean systolic ambulatory blood pressure measurement at 6 months was sustained at 12 months, providing evidence of consistent blood pressure–lowering effect. Also at 12 months, there was a reduction of mean systolic 24-hour ambulatory blood pressure of 10 mm Hg (± 17 mm Hg; P = .001) and a reduction in systolic office blood pressure of 20 mm Hg (± 23 mm Hg; P = .001). No patients had major adverse events.