Ablative Solutions, Inc., a privately-held clinical stage company, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Peregrine System™ Infusion Catheter.
The Peregrine System uses a unique, patent-pending technology to deliver diagnostic and therapeutic agents directly to the perivascular layer that surrounds blood vessels. This region is dynamic and consists of sympathetic nerves, lymphatic vessels, and a rich diversity of cells that can influence blood vessel function, repair and disease. For example, it has recently been shown that overactive sympathetic nerves residing in the perivascular space are associated with hypertension, metabolic syndrome, congestive heart failure and obesity.
“Ablative Solutions is pleased to make the Peregrine System available to clinicians to deliver therapies targeted to the perivascular zone,” said Vartan Ghazarossian, PhD, President of ASI.
“Cardiovascular disease can impact so many aspects of patient health,” observed Prof. Dr. med. Horst Sievert, Director and Founder of the Cardiovascular Center Frankfurt (CVC Frankfurt). “As we deepen our scientific understanding of the underlying disease processes, advances in technology can facilitate further insight and can aid in the development of better treatments. I am eager to work with the Ablative Solutions team to explore how to incorporate the Peregrine System into clinical practice.”