The Peregrine system infusion catheter (Ablative Solutions) has demonstrated 100% procedural success in the Peregrine post-market clinical trial, new data presented during a late-breaking session at the 2019 Cardiovascular Research Technologies (CRT) meeting (2–5 March, Washington, DC, USA) attests.
The Peregrine post-market study is a European multicentre, open-label trial that evaluated the safety and performance of the CE marked Peregrine System infusion catheter using alcohol as a neurolytic agent in 45 patients with systemic hypertension.
The efficacy endpoint of the study was met, with a reduction in mean systolic 24-hour ambulatory blood pressure of 11mmHg (±14 mm Hg, p<0.001) at six-month follow-up. Additionally, the average reduction in systolic office blood pressure was 18 mmHg (±21 mmHg, p<0.001). Antihypertensive medications were unchanged in 73% and reduced in 23% of patients at six months. The study demonstrated 100% procedural success, and the safety endpoint was met in 96% of patients. Two patients had major adverse events of periprocedural access site pseudoaneurysms, with major bleeding in one patient. There were no deaths or instances of myocardial infarction, stroke, or transient ischaemic attack.
“The Peregrine post-market study showed efficient nerve ablation with the CE marked Peregrine catheter, resulting in significantly sustained reduction in both systolic and diastolic blood pressure at six months, with the vast majority of patients not requiring an increase in the number of anti-hypertensive medications during this time,” says Felix Mahfoud, of Saarland University Hospital, Homburg, Germany.
The Peregrine system infusion catheter has received a Certificate of Conformity and has been CE marked for the infusion of a neurolytic agent (for example, alcohol) to achieve a reduction in systemic blood pressure in hypertensive patients. Designed to be performed in a short and straightforward procedure with minimal sedation required, the Peregrine catheter is engineered to target nerves known to influence the body’s regulation of blood pressure. The delivery of a neurolytic agent—dehydrated alcohol in this study—directly to the space outside of the renal artery is intended to block the overactive signalling of the sympathetic nerves, a press release explains.
The investigational Peregrine kit, which includes the Peregrine system infusion catheter (Peregrine catheter) and Ablative Solutions dehydrated alcohol, will be investigated in the TARGET BP clinical programme, which comprises two clinical trials. The global TARGET BP I trial in centres in the USA and EU is a blinded, randomised, sham-controlled study which will evaluate the safety and efficacy of the Peregrine kit in the treatment of patients with uncontrolled hypertension and who are taking two to five anti-hypertensive medications. Patient enrolment in the Target BP I trial is anticipated to begin soon. The recently initiated TARGET BP OFF-MED trial in Europe is a proof-of-concept, blinded, randomised, sham-controlled study evaluating the safety and effectiveness of the Peregrine kit for the treatment of patients with uncontrolled hypertension who are not taking anti-hypertensive medications.
“Based on early clinical results using the CE-marked Peregrine catheter, we are excited to be embarking upon the pivotal TARGET BP I Clinical trial of the investigational Peregrine kit to evaluate safety and efficacy when used in the treatment of patients with uncontrolled hypertension in conjunction with antihypertensive medications,” says David Kandzari, coprincipal investigator of the TARGET BP I trial, and director of Interventional Cardiology and chief scientific officer at Piedmont Heart Institute in Atlanta, USA.
Ablative Solutions recently announced a US$77 million financing to complete clinical trials in support of US and European regulatory submissions for the company’s minimally invasive renal denervation technology.