The first two patients in the European Peregrine system post-market study have been treated by Wojtek Wojakowski and Mariusz Hochul in Poland, Ablative Solutions has announced.
The multi-centre, European Peregrine post-market study is an open-label study, intended to compile and analyse additional safety and performance data using the Peregrine system in the treatment of systemic hypertension. The first patients were treated at an American Heart of Poland (AHP) hospital in Poland, using the Peregrine system infusion catheter with a neurolytic agent to treat sympathetic nerves in the outer layer of the renal arteries.
Woftek Wojakowski, the site principle investigator, says, “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.”
Pawel Buszman, head of the AHP, says, “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 is CE-marked to deliver neurolytic agents directly to the sympathetic nerves that reside in the peri-adventitial area of the renal artery, thereby interrupting the oversignaling of the nerves that drive essential hypertension in many patients. Vartan Ghazarossian, President of ASI, said, “We hope to demonstrate that perivascular renal denervation using a neurolytic agent (ie. dehydrated alcohol) will provide a minimally invasive approach that consistently delivers the desired therapeutic effect.”
In the USA, the Peregrine system has been 510(k) cleared by the US Food and Drug Administration (FDA) 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. The Peregrine system is intended for use by trained physicians familiar with the risks as detailed in the instructions for use.