Healthcare Industry News: peripheral artery disease
News Release - September 8, 2006
FoxHollow Announces First Patient Treated With the NightHawk(TM) System, a New Technology Enabling Real-Time Visualization During Arterial Plaque Excision in the Lower LegsREDWOOD CITY, Calif., Sept. 8 (HSMN NewsFeed) -- FoxHollow Technologies, Inc., (Nasdaq: FOXH ), today announced the first-in-man use of a new technology, which combines onboard real-time imaging with the SilverHawk(TM) Plaque Excision System. The Company's latest advance, called NightHawk, brings together optical coherence tomography (OCT) technology with the FDA-cleared SilverHawk System to allow for plaque removal in patients suffering from blocked arteries in the lower legs. The NightHawk technology is currently being evaluated through a feasibility study at a hospital in Poland.
The first 5 patients were treated at the American Heart of Poland Hospital in Bielsko this week. A team of U.S. interventional cardiologists including FoxHollow founder and CEO, Dr. John Simpson, Dr. Stefan Kiesz and Dr. Greg Robertson attended the cases. Professor Pawel Buszman is the lead Principal Investigator.
"These initial procedures with the NightHawk, although early-stage, are very encouraging and consistent with our experience in pre-clinical studies. They demonstrate the potential for real-time visualization to enhance procedural results obtained with the SilverHawk for treating patients suffering from PAD," Simpson commented. "As a result, we believe the NightHawk may enhance our ability to treat PAD patients in the near-term and may allow us to expand the use of our products to other areas of the body."
The NightHawk System utilizes fiber optic technology embedded in the catheter. While removing plaque, the physician has the ability to visualize the intravascular placement of the device within the vessel. Additional advantages of OCT include reductions in the use of potentially harmful X-Ray imaging and contrast dye which may present potential risks to patients with pre-existing kidney or heart conditions.
"I was extremely impressed with the performance of the NightHawk and its ability to provide real-time images inside the arteries of the lower legs," noted Dr. Greg Robertson. "This enables the treating physician to visualize target tissue," he added.
Earlier this year, FoxHollow announced a goal of achieving the first-in- man use of the NightHawk by the end of 2006. After early success was confirmed in pre-clinical studies, the Company was able to realize this goal two months prior to the expected date.
About FoxHollow Technologies, Inc.
FoxHollow Technologies, Inc., develops and markets minimally invasive plaque excision devices for the treatment of peripheral artery disease (PAD). An estimated 12 million people in the U.S. are thought to suffer from PAD, with 2.5 million patients currently diagnosed. 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 system is a minimally invasive method of removing the obstructive plaque and restoring blood flow to the legs and feet. For more information, please visit our website at http://www.foxhollowtech.com .
Forward Looking Statements
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, statements concerning the ability of the NightHawk to enhance treatment of patients with PAD and allow for the use of our products in other areas of the body are forward-looking statements. Forward-looking statements are based on management's current, preliminary expectations and are subject to risks and uncertainties, which may cause FoxHollow's actual results to differ materially from the statements contained herein. Risks and uncertainties are included under the captions, "Managements' Discussion and Analysis of Financial Condition and Results of Operations," and "Risk Factors," in our quarterly report on Form 10-Q as filed with the Securities and Exchange Commission on August 9, 2006, which is on file with the SEC and available on our investor relations website at http://investor.foxhollowtech.com and on the SEC's website at 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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