Ablative Solutions announced today that it received positive results at six months from its post-market study for the Peregrine System infusion catheter, which accomplishes renal denervation by delivering microdoses of dehydrated alcohol.
The results from the study of the safety and efficacy of the CE-Marked Peregrine System have been published in the Journal of the American College of Cardiology: Cardiovascular Interventions.
San Jose, Calif.-based Ablative Solutions tested its Peregrine System infusion catheter by using it to deliver a neurolytic agent (dehydrated alcohol) into the space outside the renal arteries in 45 patients with systemic hypertension. All people included in the study were taking at least three anti-hypertensive medications, according to a news release.
At six months, 96% of patients met the primary safety endpoint of the study, which Ablative Solutions defined as the absence of periprocedural major vascular complications, major bleeding, acute kidney injury or death within one month. The company said medication adherence was monitored and remained stable throughout the study.
“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,” Saar University Hospital (Germany) professor Dr. Felix Mahfoud said in a news release. “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.”
The Peregrine system catheter is included in the company’s investigational Peregrine Kit, which is being investigated in the Target BP clinical program that consists of two clinical trials conducting renal denervation procedures.
“Publication of the Peregrine post-market study results in a respected peer-reviewed journal is a significant milestone for Ablative Solutions and shows the potential of the Peregrine System to become an important adjunctive therapy for managing uncontrolled blood pressure in this large patient population,” Ablative Solutions president & CEO Kate Rumrill said in the release. “We are committed to robust clinical research through our ongoing Target BP clinical trials program to further substantiate the procedural, clinical, and health-economic benefits of the Peregrine catheter for the treatment of hypertension.”
