SilverHawk Plaque Excision Shown to Minimize the Amputation Rate in Multi-Center Publication of Patients With Critical Limb Isch
February 15 2006 - 9:00AM
PR Newswire (US)
Study Published in Peer-Reviewed Journal of Endovascular Therapy
REDWOOD CITY, Calif., Feb. 15 /PRNewswire-FirstCall/ -- In a
multi-center evaluation of patients with critical limb ischemia
(CLI), Dr. David Kandzari of Duke Medical Research Institute and
colleagues report that 82% of patients who received plaque excision
avoided an amputation or received a less extensive amputation than
originally planned. The patient population was comprised of those
who suffer from the most severe form of peripheral artery disease
(PAD). Six months after the plaque excision procedure, 96% of the
lesions remained free from re-treatment in patients without
amputation. Results of the study were published in the February
2006 issue of the peer-reviewed publication The Journal of
Endovascular Therapy. Patients enrolled in the study were treated
with the SilverHawk Plaque Excision System, a device used to remove
plaque caused by PAD and restore blood flow to the legs, feet and
toes. When PAD progresses to a more severe state in the lower
extremities, it is called critical limb ischemia. CLI is an
obstruction of the arteries that decreases blood flow to the legs
and feet, causing severe pain, non-healing sores, and tissue loss.
An estimated 1.5 to 2 million Americans suffer from CLI. As a
result, at least 150,000 amputations are still performed each year
in the U.S. An estimated 25% of those who receive an amputation
will die within 1 year. Another 25% will receive a second
amputation within the year. The CLI patients treated with plaque
excision were prospectively followed for six months at seven U.S.
institutions. A retrospective review of this patient subset was
completed. Overall, a high prevalence of cardiovascular risk
factors was identified: 78% of patients had diabetes; 57% had a
history of coronary artery disease, and 47% had kidney impairment.
Over 40% of the patients already had a previous leg artery
procedure. "In general, the patients treated were among the sickest
we see and faced a high likelihood of losing a leg. Amputation was
already planned before these procedures for 48 of 76 limbs
treated," said Dr. Kandzari. "The fact that 82% avoided amputation
or were able to minimize the extent of the amputation is a
remarkable result that validates the important role plaque excision
plays in limb salvage." In the evaluation, plaque excision was
performed in 69 patients (76 limbs, 159 lesions) with procedural
success achieved in 99% of cases. In the majority of the patients
treated, the SilverHawk System was used as the only therapy. Stents
were placed in just 6% of the cases. "We desperately need an answer
for these patients, and we are very encouraged by the promise
plaque excision shows in helping CLI patients avoid amputation,"
Dr. Kandzari added. As part of a continuing commitment to prevent
amputations and return patients to mobility, FoxHollow has
undertaken a national initiative to educate physicians on treating
CLI. In the last nine months, the company has hosted three national
medical meetings called, "Below the Knee: New Advances in Critical
Limb Ischemia." To date, over 550 cardiologists, vascular surgeons
and interventional radiologists from across the country have chosen
to attend. Through live cases and presentations delivered by a
multi-disciplinary faculty of 18 physicians, the courses focus on
helping physicians develop the technical expertise required for
successful limb salvage. 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/. Contacts: Matt Ferguson Chief
Financial Officer 650-421-8501 Jonathan Menachem Investor Relations
650-421-8449 Robin Gaffney Media Relations 650-421-8614 FCMN
Contact: rgaffney@foxhollowtech.com DATASOURCE: FoxHollow
Technologies, Inc. CONTACT: Matt Ferguson, Chief Financial Officer,
+1-650-421-8501, or Jonathan Menachem, Investor Relations,
+1-650-421-8449, or , or Robin Gaffney, Media Relations,
+1-650-421-8614, or , all of FoxHollow Technologies, Inc. Web site:
http://www.foxhollowtech.com/
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