08.26.15
Ablative Solutions Inc.’s Peregrine system infusion catheter for hypertension has won CE Mark approval, the devicemaker recently announced.
The device works by infusing a neurolytic agent into the perivascular space surrounding the renal artery, which targets high blood pressure-causing sympathetic nerves. This targeted approach offers physicians a new tool to help manage patients with high blood pressure.
The company has begun enrolling drug-resistant hypertension patients in a European clinical trial for drug-resistant hypertension. “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,” said Prof. Wojtek Wojakowski, principal iInvestigator of the study.
The European clinical trial will continue to enroll and follow patients to confirm the safety and the clinical benefits associated with use of the device. Ablative Solutions also plans to initiate a post-market study in Europe to gather additional clinical and health-economic data in support of commercialization.
“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.”
The devicemaker also plans a trial in the United States, where the product has been designated investigational use only for hypertension. Ablative Solutions received 510(k) clearance from the U.S. Food and Drug Administration to use the catheter to infuse diagnostic and therapeutic agents in the perivascular area of the peripheral vasculature.
Based in Kalamazoo, Mich., (with offices in Menlo Park, Calif.), Ablative Solutions is a venture-backed, privately-held clinical stage company that develops hypertension treatment technology. It was founded in 2011 by medical device entrepreneurs Tim Fischell, M.D., and David Fischell, Ph.D.
The device works by infusing a neurolytic agent into the perivascular space surrounding the renal artery, which targets high blood pressure-causing sympathetic nerves. This targeted approach offers physicians a new tool to help manage patients with high blood pressure.
The company has begun enrolling drug-resistant hypertension patients in a European clinical trial for drug-resistant hypertension. “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,” said Prof. Wojtek Wojakowski, principal iInvestigator of the study.
The European clinical trial will continue to enroll and follow patients to confirm the safety and the clinical benefits associated with use of the device. Ablative Solutions also plans to initiate a post-market study in Europe to gather additional clinical and health-economic data in support of commercialization.
“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.”
The devicemaker also plans a trial in the United States, where the product has been designated investigational use only for hypertension. Ablative Solutions received 510(k) clearance from the U.S. Food and Drug Administration to use the catheter to infuse diagnostic and therapeutic agents in the perivascular area of the peripheral vasculature.
Based in Kalamazoo, Mich., (with offices in Menlo Park, Calif.), Ablative Solutions is a venture-backed, privately-held clinical stage company that develops hypertension treatment technology. It was founded in 2011 by medical device entrepreneurs Tim Fischell, M.D., and David Fischell, Ph.D.