February 15, 2016
Ablative Solutions Commences European Peregrine Postmarket Study for Renal Denervation
February 16, 2016—Ablative Solutions, Inc. announced that Professors Wojtek Wojakowski, MD, and Mariusz Hochul, MD, have treated the first two patients in the European Peregrine postmarket study, which is enrolling patients to receive targeted therapy using the company’s CE Mark-approved Peregrine system infusion catheter with a neurolytic agent to treat sympathetic nerves located in the outer layer of the renal arteries.
According to the company, the multicenter, open-label clinical trial is being launched in centers across Europe to collect and evaluate additional safety and performance data using the Peregrine system for the treatment of patients with systemic hypertension.
In the company’s press release, Prof. Wojakowski, the site Principal Investigator, observed that both procedures went smoothly and commented, “We were able to use the Peregrine system to efficiently deliver targeted therapy in these patients with systemic hypertension. In both cases the procedure was essentially painless for the patients, without the use of sedation.”
Professor Pawel Buszman, MD, head of The American Heart of Poland Group that directs the hospital at which the patients were treated, added, “We are excited to be working with Ablative Solutions in the clinical evaluation using their innovative therapy to address the treatment of severe hypertension. This is a vital area of interest for us, since many patients in Poland and throughout Europe face serious health complications from challenges in adequately managing their hypertension with medications.”
In Europe, the Peregrine system has received CE Mark approval to deliver neurolytic agents directly to the sympathetic nerves that reside in the periadventitial area of the renal artery, thereby interrupting the oversignaling of the nerves that drive essential hypertension in many patients.
In the United States, the Peregrine system has been received 510(k) clearance from the US Food and Drug Administration for the infusion of diagnostic and therapeutic agents into the perivascular area; however, it is not currently cleared or approved for the treatment of hypertension, advised the company.