Healthcare Industry News: SilverHawk
News Release - May 21, 2007
FoxHollow Provides Update on Regulatory Process for Its NightHawk(TM) SystemREDWOOD CITY, Calif., May 21 (HSMN NewsFeed) -- FoxHollow Technologies, Inc. (Nasdaq: FOXH ), today announced that the company has plans to conduct a clinical study with its NightHawk Plaque Excision System under an Investigational Device Exemption application (IDE). In support of the IDE, FoxHollow has decided to forego a previously submitted 510(k) notification to the FDA for this technology.
With acceptance of the IDE application from the FDA, FoxHollow hopes to begin a U.S. clinical study to gain important insight and experience for the NightHawk System. The study will evaluate the NightHawk's ability to estimate the location of the catheter to the vessel wall during peripheral plaque excision, whereas the 510(k) submission sought approval for a more limited set of functional claims.
The company hopes to initiate enrollment in this trial during the third quarter of 2007. It believes that a clinical trial will facilitate use of the device among a group of experienced SilverHawk users in the U.S. sooner than if it had waited for a 510(k) approval.
The NightHawk System brings together optical coherence tomography (OCT) imaging 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 within the artery. The OCT imaging capability is designed for use as an adjunct to conventional angiography during plaque excision procedures.
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 the benefits of its regulatory strategy for the NightHawk System and the commencement of the associated clinical study 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 in the "Risk Factors" section of our most recent quarterly report on Form 10-Q for the quarter ended March 31, 2007. This quarterly report was filed with the SEC on May 9, 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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