FDA gives approval for use of device by Ablative Solutions

Tim Fischell, MD, FACC

Sympathetic nerves, lymphatic vessels, and a rich diversity of cells that can influence blood vessel function, repair and disease are found in the layer that surrounds blood vessels.

And 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.

Hypertension affects an estimated 1 billion people worldwide, and an estimated 65 million adults in the United States. Hypertension is a major risk factor for heart disease, stroke, congestive heart failure, metabolic syndrome, obstructive sleep apnea and kidney disease.

One out of every six adult deaths is attributable to hypertension, and the economic burden in the US exceeds $76.6 Billion. The World Health Organization (WHO) estimates that worldwide, more than 17 million deaths each year are attributable to cardiovascular disease, with hypertension being a substantial contributor to these deaths.

A device that delivers diagnostic and therapeutic agents directly to this perivascular layer, developed by Ablative Solutions, Inc., has received U.S. Food and Drug Administration (FDA) approval.

"Ablative Solutions is pleased to make the Peregrine System available to clinicians to deliver therapies targeted to the perivascular zone," says Vartan Ghazarossian, PhD, President of ASI.

Ablative Solutions, a privately-held clinical stage company, was founded in 2011 by Tim Fischell, MD, FACC, and David Fischell, PhD, and is headquartered in Kalamazoo and offices in Menlo Park, Cal.

Source: Ablative Solutions

FDA gives approval for use of device by Ablative Solutions

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