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New Vascular Therapy Device Receives FDA Clearance

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New Vascular Therapy Device Receives FDA Clearance

New Vascular Therapy Device Receives FDA Clearance

October 06, 2002

Washington, D.C. – Sept. 25, 2002 – The U. S. Food and Drug Administration has cleared the PolarCath Peripheral Transluminal Angioplasty System, a novel interventional angioplasty device that treats clogged leg arteries using a liquid nitrous oxide filled balloon to open the vessel, it was announced today at the annual Transcatheter Cardiovascular Therapeutics (TCT) symposium, an international vascular therapy meeting. It is expected to be commercially available during the first quarter of 2003.

The PolarCath system was developed by CryoVascular Systems, a privately held Silicon Valley start-up company that is focusing on state-of-the-art interventional therapy for the treatment of vascular disease.

“This is good news for patients and provides a safe and effective new option for the millions of people whose have quality of life is impacted by symptomatic arterial diseaseclogged arteries in their legs,” said James Joye, D.O., an interventionalist and medical director of CryoVascular Systems.

“We are extremely pleased to receive our first marketing authorization for the PolarCath System in the United States,” said Jeff Gold, president and CEO of the company. “Based on the worldwide clinical experience to date, we believe the PolarCath system offers interventionalists an exciting alternative to treat their patients who have peripheral vascular disease.”

The company also has an investigational device under FDA review forfor the treatment of ing clogged coronary artery diseaseies.

As the population continues to age, there has been a significant n incincreased in the incidence of peripheral vascular disease (PVD), a condition in which upper and lower leg arteries become blocked by plaqueclogged, resulting in an increased demand for treatment options. It is estimated that more than 10 million people in the US alone suffer from PVDmore than 10 million people in the U.S. are affected by PVD. Just as heart arteries can become clogged and cause pain, potentially leading to a heart attack or stroke, PVD can cause lifestyle-limiting leg pain and, in severe cases, can result in amputation. PVD is a warning sign of system-wide vascular disease, and there is a high correlation between PVD and coronary disease.

With the PolarCath angioplasty procedure, the nitrous oxide is used to inflate the balloon catheter instead of saline, which is normally used in conventional angioplasty. Since the PolarcCath angioplasty procedure is similar to that of traditional conventional balloon angioplasty, additional training for physicians will be minimal. The unique balloon catheter, a single-use disposable device used in the PolarCath system in the treatment of peripheral arteries, has already received the CE Marking in Europe and has been commercially available since early 2002.

For more information, visit the CryoVascular Web site at www.cryoinc.com.


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