Ablative Solutions said it received CE Mark approval for its Peregrine infusion ablation catheter for treating uncontrolled hypertension. The company began testing Peregrine last year in Poland.
The Peregrine system infuses neurolytic agents into the perivascular space surrounding the renal artery to ablate the sympathetic nerves that contribute to hypertension.
Kalamazoo, Mich.-based Ablative Solutions said it’s enrolling patients in a clinical trial for the treatment in Europe. The company said it also plans to initiate a post-market study to gather additional clinical data on the treatment.
"I have had the opportunity to be 1 of the 1st 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," principal investigator Dr. Wojtek Wojakowski said in prepared remarks.
In the U.S., the company has received 510(k) clearance from the FDA as a "tool for the infusion of diagnostic and therapeutic agents into the perivascular area of a peripheral vasculature," Ablative Solutions said. The company said it’s still in the planning stage for a U.S. clinical trial for the hypertension indication.
"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. 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," president Jon Hoem said in a press release.