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