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Efficient and safe neurolysis is key to performing a successful renal denervation procedure. Chemical neurolysis based on the perivascular infusion of alcohol via endovascular technique represents a safe and effective method which includes performance characteristics essential to the procedure.
The Peregrine System™ Infusion Catheter contains 3 micro-needles which are deployed through the media of an artery into the adventitial region. The device is directed into the renal arteries using standard endovascular techniques. A small volume of Dehydrated Alcohol (0.3 mL-0.6 mL) when infused through the catheter, distributes circumferentially and axially along the vessel. The infusion is performed at a single site of each renal artery. Alcohol is a well-characterized neurolytic agent and functions in a consistent, dose-dependent fashion by a combination of cellular dehydration, extraction of lipids, and precipitation of proteins of target tissue. Targeted delivery of the alcohol to the perivascular space ensures that the perirenal nerves are destroyed while preserving adjacent tissue.
No procedural vascular adverse events have been reported with the use of the Peregrine Catheter. The delivery mechanisms of the device are highly flexible and atraumatic. Alcohol, as a hygroscopic agent, distributes evenly at the site of infusion. Ablation depths of up to 13 mm, as measured from the IEL, are observed. Alcohol is distributed circumferentially around the vessel (with some variation due to adjacent anatomic structures) to form a ‘cuff’ surrounding the artery at the infusion site. An ablation area of up to 57 mm2 have been reported based on morphometric measurements. Renal norepinephrine has been reduced by 64%-86% compared to controls. Since a single deployment and infusion is required at each renal artery, procedure time, contrast, radiation exposure are all reduced.
Preclinical data has shown that endovascular alcohol-mediated renal denervation using the Peregrine Catheter incorporates the performance characteristics required to produce more effective neurolysis of the sympathetic perirenal nerves. On-going and completed clinical trials continue to demonstrate promising results of both safety and effectiveness.