Ablative Solutions Receives FDA Clearance for the Peregrine System(™) Infusion Catheter
Newswise — KALAMAZOO, Mich., April 2, 2014 /PRNewswire/ -- 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(TM) 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."
Ablative Solutions was founded in 2011 by Tim Fischell, MD, FACC, and David Fischell, PhD, 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.
This press release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. Information in this press release, which is not historical, is forward-looking and involves a number of risks and uncertainties. Investors are cautioned not to put any undue reliance on any forward-looking statement. ASI's actual results may differ materially from ASI's historical results of operations and those discussed in the forward-looking statements for various reasons, including, but not limited to ASI's ability to carry out its business plan, successful development and commercial acceptance of its products, ability to fund development necessary for existing products and for the pursuit of new product opportunities, ability to hire required personnel, the risk of whether products result from development activities, protection of ASI's intellectual property portfolio, the risk associated with obtaining the necessary regulatory approvals, the ability to obtain foreign regulatory approvals for products and to establish marketing arrangements in countries where approval is obtained, and other potential factors.
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Vartan Ghazarossian, PhD