First Patient Enrolled in New Prospective, Multi-Center Outcomes Study on SilverHawk Plaque Excision
June 29 2006 - 5:15PM
PR Newswire (US)
Additional Randomized, Controlled Study Evaluating Plaque Excision
Vs. Surgical Bypass Announced REDWOOD CITY, Calif., June 29
/PRNewswire-FirstCall/ -- 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
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, 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 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. Investor Relations: Matt Ferguson Chief Financial Officer
650-421-8449 Media Relations: Robin Gaffney 650-421-8614
DATASOURCE: FoxHollow Technologies, Inc. CONTACT: Investor
Relations: Matt Ferguson, Chief Financial Officer, +1-650-421-8449
or , or Media Relations: Robin Gaffney, +1-650-421-8614 or , both
of FoxHollow Technologies, Inc. Web site:
http://www.foxhollowtech.com/
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