Ablative Solutions (ASI) announced that it has received the CE Certificate of Conformity allowing ASI to apply the CE Mark to the Peregrine System Infusion Catheter.
This will enable the Peregrine System to be used to treat hypertensive patients in Europe with the infusion of a neurolytic agent into the perivascular space surrounding the renal artery, targeting the sympathetic nerves that contribute to hypertension. This targeted approach offers physicians a new tool to help manage patients with high blood pressure.
Ablative Solutions is currently enrolling patients in the European Peregrine clinical trial for drug-resistant hypertension.
The Principal Investigator of the study, Prof. Wojtek Wojakowski, stated: "I have had the opportunity to be one of the first users of the Peregrine System Infusion Catheter in Europe. Early results suggest that perivascular alcohol denervation is a promising approach. I’m impressed by how simple and rapid the procedure is with this technology."
This clinical study will continue to enroll and follow patients to confirm the safety and the clinical benefits associated with use of the device.
"This is a major milestone for ASI, and comes at a time when there is a great need to address uncontrolled hypertension, a significant disease which affects millions of patients," said Jon H. Hoem, President of Ablative Solutions Europe.
Ablative Solutions plans to initiate a post-market study in Europe to gather additional clinical and health-economic data in support of commercialization.
The company is also in the planning stage of a randomized clinical trial in the US to support marketing permission for the treatment of hypertension.
In the US, the Peregrine System has received 510(k) clearance as a tool for the infusion of diagnostic and therapeutic agents into the perivascular area of the peripheral vasculature; however, it remains investigational for the treatment of hypertension.