News | April 02, 2007

FoxHollow Submits NightHawk Peripheral Visualization System to FDA

April 3, 2007 —FoxHollow Technologies Inc. has announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for its NightHawk Plaque Excision System. The intended use of the NightHawk System is in the evaluation of peripheral vascular morphology.

The NightHawk System brings together optical coherence tomography (OCT) technology with the FDA-cleared SilverHawk System. The NightHawk device utilizes fiber optic technology embedded in the catheter and allows the physician to visualize the vascular morphology and wall structures. The OCT embedded catheters are designed for use as an adjunct to conventional angiography to provide an image of the vessel lumen and wall structures.

"We believe that if and when approved, the NightHawk will be useful in treating PAD patients, and may someday allow us to eventually expand the use of our products to other areas of the body," said John Simpson, Ph.D., M.D., FoxHollow's founder and Chief Executive Officer.

In October 2006, FoxHollow announced the first in-man use of this new technology with encouraging results. Patients were treated at the American Heart of Poland Hospital in Bielsko by lead investigator Professor Pawel Buszman. The procedures were also attended by a team of U.S. interventional cardiologists, which included FoxHollow founder and CEO, Dr. John Simpson, Dr. Stefan Kiesz and Dr. Greg Robertson. In January 2007, FoxHollow conducted additional evaluations with the NightHawk technology by Professor Horst Sievert at the CardioVascular Center, Frankfurt Germany.

For more information visit www.foxhollowtech.com.

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