The US Food and Drug Administration (FDA) has granted 510(k) clearance for Ablative Solutions' 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, 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 Centre 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."

Ablative Solutions was founded in 2011 by Tim Fischell, managing director, FACC, and David Fischell, and is headquartered in Kalamazoo, MI, with offices in Menlo Park, CA.  Ablative Solutions has developed endovascular catheters that are designed to provide a durable and cost-effective means for the targeted delivery of diagnostic and therapeutic agents to the perivascular space of blood vessels to address life-threatening diseases.