Healthcare Industry News: intended use
News Release - April 2, 2007
FoxHollow Announces FDA 510(k) Submission for the NightHawk(TM) SystemSubmission represents significant milestone towards the commercialization of the Company's Proprietary Technology To Enable Real-Time Visualization Of Peripheral Vascular Morphology
REDWOOD CITY, Calif., April 2 (HSMN NewsFeed) -- FoxHollow Technologies, Inc. (Nasdaq: FOXH ), today announced a 510(k) premarket notification submission to the U.S. Food and Drug Administration for its NightHawk(TM) 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.
"Our submission of the 510(k) marks a major milestone in our progress towards commercializing the NightHawk, and to our goal of providing the best care for patients suffering from PAD," said John Simpson, Ph.D., M.D., FoxHollow's founder and Chief Executive Officer. "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," he commented.
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.
About FoxHollow Technologies, Inc.
FoxHollow Technologies, Inc. develops and markets endovascular therapeutic devices for the treatment of peripheral artery disease (PAD). PAD results from plaque that accumulates in the arteries and blocks blood flow in the legs. These blockages can result in severe pain for patients and very limited physical mobility. The company's SilverHawk® Plaque Excision System is a minimally invasive method of removing obstructive plaque and restoring blood flow to the legs and feet. FoxHollow also markets the Rinspirator® System for removing thrombus, or blood clots, from occluded arteries in patients suffering from PAD or coronary artery disease (CAD). For more information, please visit our website at http://www.foxhollowtech.com.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this press release regarding FoxHollow's business that are not historical facts may be "forward-looking statements" that involve risks and uncertainties. Specifically, the company's expectations regarding FDA approval and use of its products in various locations within the body are forward- looking statements involving risks and uncertainties Forward-looking statements are based on management's current, preliminary expectations, and are subject to risks and uncertainties that could cause actual results to differ from the results predicted and which are included under the caption, "Factors Affecting Future Operating Results," in the "Risk Factors" section of our most recent annual report on Form 10-K for the year ended December 31, 2006. This annual report was filed with the SEC on March 13, 2007, and is available on our investor relations website at http://investor.foxhollowtech.com and on the SEC's website at http://www.sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. FoxHollow undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.
Source: FoxHollow Technologies
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