Angiotech Pharmaceuticals announces FDA approval of TAXUS(R) Libert (R) Long Stent
16 Juli 2009 - 6:51PM
PR Newswire (US)
VANCOUVER, July 16 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP) today
announced that its corporate partner, Boston Scientific Corporation
(NYSE:BSX) has received approval from the U.S. Food and Drug
Administration (FDA) to market its TAXUS(R) Libert (R) Long
Paclitaxel-Eluting Coronary Stent System, a next-generation
drug-eluting stent (DES) designed for long lesions. At 38 mm, it is
the longest available DES, providing doctors an option that can
potentially reduce the number of stents used in more complex cases,
simplifying procedures and reducing costs. It affords a more
efficient treatment option for the estimated 8 to 10 percent(1) of
patients with long lesions. Boston Scientific plans to launch the
product in the U.S. next month. It received CE Mark approval in
2007. "The TAXUS Libert Long Stent offers physicians and patients
distinct advantages compared to using two overlapping drug-eluting
stents," said Mark Turco, M.D., FACC, FSCAI, Director of the Center
for Cardiac Vascular Research at Washington Adventist Hospital,
Takoma Park, Maryland. "In the ATLAS Long Lesion Trial, the 38 mm
TAXUS Libert Stent significantly reduced myocardial infarction when
compared to the TAXUS(R) Express(R) Stent, making the TAXUS Libert
Long Stent an attractive option for interventional cardiologists
faced with long, challenging lesions." The TAXUS ATLAS Long Lesion
Trial reported a significant 79 percent reduction in the rate of
nine-month myocardial infarction for the TAXUS Libert Long Stent as
compared to the TAXUS Express Stent control (1.3% vs. 6.3%,
p=0.026). At two years, the composite measure of cardiac death or
myocardial infarction showed a significant 63 percent reduction for
the TAXUS Libert Long Stent compared to the TAXUS Express Stent
(3.5% vs. 9.4%, p=0.0426). The rate of stent thrombosis at two
years was zero percent for the TAXUS Libert Long Stent and 0.8
percent for the TAXUS Express Stent(2). "Today's approval of the
TAXUS Libert Long Stent, along with the approval of the TAXUS
Libert Atom(TM) Stent in May, demonstrates the strength and breadth
of the paclitaxel platform," said Dr. William Hunter, President and
CEO of Angiotech. "We are pleased with the progress that Boston
Scientific continues to make with TAXUS stents." Boston Scientific
has the industry's widest range of coronary stent sizes. The TAXUS
Libert Stent Series is now available in 92 sizes, ranging from 2.25
mm to 4.0 mm in diameter and from 8 mm to 38 mm in length. TAXUS
Stents have been evaluated by the industry's most extensive
randomized, controlled clinical trial program, with follow-up to
five years in some cases. These trial results have been
supplemented by data on more than 35,000 patients enrolled in
post-approval registries. To date, approximately 11 million Boston
Scientific stents have been implanted globally, making them the
world's most frequently used stents. -----------------------------
(1) Percentage estimates from April 2009 Millennium Research Group
report and ARRIVE 1 and 2 registries. (2) In the TAXUS ALTAS Long
Lesion Trial, the TAXUS Libert Long (38mm) Stent met its primary
endpoint of non-inferiority to the TAXUS Express control Stent in
nine-month percent diameter stenosis (31.7% vs. 32.6%, p=0.71) and
reported a 36 percent reduction in MACE (9.4% vs. 14.8%, p=0.16).
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Except as required by law, we disclaim any obligation to update any
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any of the forward-looking statements contained in this press
release to reflect future results, events or developments. About
Angiotech Pharmaceuticals Angiotech Pharmaceuticals, Inc. is a
global specialty pharmaceutical and medical device company with
over 1,500 dedicated employees. Angiotech discovers, develops and
markets innovative treatment solutions for diseases or
complications associated with medical device implants, surgical
interventions and acute injury. To find out more about Angiotech
(NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), please visit our website at
http://www.angiotech.com/. DATASOURCE: Angiotech Pharmaceuticals,
Inc. CONTACT: DeDe Sheel, Investor Relations and Corporate
Communications, Angiotech Pharmaceuticals, Inc., (415) 293-4412,
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