Healthcare Industry News: SilverHawk
News Release - June 29, 2006
First Patient Enrolled in New Prospective, Multi-Center Outcomes Study on SilverHawk Plaque ExcisionAdditional Randomized, Controlled Study Evaluating Plaque Excision Vs. Surgical Bypass Announced
REDWOOD CITY, Calif., June 29 (HSMN NewsFeed) -- A 65-year-old diabetic female with severe leg pain was the first patient to be enrolled today in a new clinical trial called SWIFT. SWIFT is a non-randomized, multi- center study assessing the long-term outcomes for patients with Peripheral Arterial Disease (PAD) treated with the SilverHawk(TM) Plaque Excision System. After treatment with plaque excision, 100 patients will be followed for a year using duplex ultrasound, and in some cases, also will be evaluated using CT angiography. FoxHollow Technologies also announced a new randomized, controlled, multi-center study set to begin later this year. The PROOF study will compare SilverHawk to open surgical bypass for patients who are at extremely high risk for limb loss due to a severe form of PAD known as Critical Limb Ischemia (CLI).
The first SWIFT patient was treated by Dr. Jeffrey Martinez, a vascular surgeon at Baptist Medical Center in San Antonio, TX. Baptist is one of 10 hospitals participating in the study. Data collected by these sites will be submitted to two independent third party core labs for review. University of Washington Medical Center will handle the duplex ultrasound analysis. Quantitative vascular angiographic assessment will be directed by Dr. Jeff Popma, an interventional cardiologist at Brigham and Women's Hospital in Boston, MA.
"With over 800 patients enrolled, the TALON study showed us that plaque excision was an effective method of treatment for patients with significant blockages in the arteries above and below the knee," said Dr. James McKinsey, Site Chief of Vascular Surgery at Columbia University of the Columbia/ Weil Cornell Division of Vascular Surgery, and principal investigator of SWIFT. "The SWIFT study is designed to provide definitive objective data confirming the high clinical success, durability and safety that was demonstrated with plaque excision in the initial TALON registry."
Patient enrollment in the new PROOF study is expected to begin by the end of this year. The study will randomize 400 patients with critical limb ischemia either to SilverHawk or surgical bypass. The primary study endpoint is amputation-free survival. The study also will measure 10 additional endpoints such as limb salvage, quality of life, re-intervention rates and the cost efficiency of each procedure. Patients will be followed for 5 years post-procedure with interim outcomes analysis to be reported initially at 6 months and 1 year.
"Bypass surgery is still considered the standard of care, despite the fact that this approach is a very invasive one that typically requires long recuperation periods and may be associated with perioperative complications given that these patients often have many coexisting illnesses," said Dr. David Kandzari, interventional cardiologist at Duke University Medical Center and the Duke Clinical Research Institute, and co-principal investigator on the PROOF study.
"We know from clinical practice that minimally invasive alternatives such as plaque excision provide exceedingly good outcomes for patients with short recovery times. We expect this study to provide compelling evidence that an endovascular option such as plaque excision is an excellent alternative to bypass surgery with beneficial impacts on safety, efficacy, quality of life and cost."
In addition to these two new trials, FoxHollow is supporting a number of studies related to its expanding biologics program. The largest of these studies is LEAP, a large, multi-center, multi-arm trial involving patients who have arterial blockages in both of their legs. Over 60 hospitals across the country are participating.
Patients enrolled in LEAP will undergo plaque excision in one leg, receive one of three study drugs or a placebo for a period of time, and then undergo plaque excision in the other leg. Plaque samples from both legs will be analyzed to uncover gene and protein differences that might lead to the discovery of new biomarkers for atherosclerotic disease, and potentially provide an effective tool to accelerate drug development. The identification of novel biomarkers may someday enable physicians to understand and treat each patient's vascular disease on the basis of the individual's unique biological profile.
About FoxHollow Technologies, Inc.
FoxHollow Technologies, Inc. (Nasdaq: FOXH ) 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 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 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, statements concerning the timing of clinical studies and expectations regarding clinical study outcomes are forward-looking statements within the meaning of the Safe Harbor. 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. The potential risks and uncertainties that could cause actual results to differ from the results predicted are included under the captions "Management's 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 May 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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