Ablative Solutions, Inc. has received CE Mark approval of its the Peregrine System™ Infusion Catheter, more evidence that all may not be dead in renal denervation therapy.
Despite that watershed moment early in 2014 when the first significant sham-controlled study suggested Renal Denervation might be more placebo than real, the therapy has not gone away, certainly in Europe. And despite the immediate exit by companies including Covidien, many of the major players are still plugging away with their technologies, hoping and believing that the original Medtronic device was either not sufficiently capable, or not having enough effect to yield a positive clinical outcome in refractory hypertensive patients.
With the questions remaining about the original ablative techniques, which were mostly radiofrequency-energy-induced, so along comes a company offering a different approach. Ablative Technologies says its Peregrine system involves the infusion of a neurolytic agent into the perivascular space surrounding the renal artery, targeting the sympathetic nerves that contribute to hypertension.
With its CE mark the Peregrine System can now to be used to treat hypertensive patients in Europe. In the US, the Peregrine System has received FDA 510(k) clearance for use 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.
So where’s the evidence that the Peregrine system can effect reduction in blood pressure in its target patient group? Well, what’s striking is that its press release announcement doesn’t cite a single human paper. It looks like the approval was based on pre-clinical models which are about to be presented at the EuroPCR meeting later this month.
The company refers to its European Peregrine clinical trial for drug-resistant hypertension, which it says is currently enrolling patients to confirm the safety and the clinical benefits associated with use of the device. With its newly gained marketing approval, the company is also now able to initiate a post-market study in Europe to gather additional clinical and health/economic data in support of commercialization. It is also in the planning stage of a randomized clinical trial in the US to support marketing permission for the treatment of hypertension.
Principal Investigator 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. The procedures I have performed take only about 15 minutes and have been performed under mild or no sedation, without the need for an anesthesiologist, thereby enabling same-day discharge.”
“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. “We’ve learned from previous clinical trials that effectively interrupting the sympathetic nerve signals can reduce blood pressure. A key advantage of the Peregrine System is that it infuses the ablative therapy directly into the perivascular region, where the nerves reside, and provides deep and circumferential distribution, which we believe will result in a more efficient denervation. We look forward to working with European clinicians to document the full potential of ASI’s technology.”
Source: Ablative Solutions, Inc.