Angiotech's Licensee, Cook Medical, Announces CE Mark Approval and European Launch of the Zilver(R) PTX(R) Stent

    The World's First Peripheral Drug-Eluting Stent Now Available in Europe

    VANCOUVER, Aug. 11 /CNW/ - Angiotech Pharmaceuticals, Inc. (NASDAQ:   ANPI,
TSX: ANP) today announced Cook Medical, a license holder of Angiotech's
paclitaxel technology, reported CE Mark approval and limited commercial launch
of the Zilver(R) PTX(R) Drug-Eluting Peripheral Stent in Europe. This approval
represents a global landmark in bringing drug-eluting stent (DES) technology
to people suffering from peripheral artery disease (PAD), a chronic disease
affecting tens of millions of patients worldwide that is a leading cause of
leg amputation and shortened lifespan.
    "The awarding of the CE Mark is set to herald a revolution in the
treatment of peripheral arterial disease," said Dr. Michael Dake, Professor in
the Department of Cardiothoracic Surgery at Stanford University Medical School
and Medical Director of the Cath/Angio Laboratories at Stanford University
Medical Center, Palo Alto, California. "This global study demonstrates that
the Zilver PTX has the integrity, safety and durability needed to successfully
address many of the well-known limitations of current treatments for the
management of PAD."
    "Cook is to be congratulated for succeeding where many others have failed
in making drug-eluting stent technology a reality for patients with peripheral
vascular disease," said Dr. Bill Hunter, President and CEO of Angiotech. "The
Zilver PTX stent platform has shown tremendous mechanical performance in
clinical trials, and when combined with the proven benefits of paclitaxel in
the prevention of restenosis, the Zilver PTX is poised to become the first
choice for interventionalists in the management of this common medical
    For the first time, patients in Europe today had access to a highly
effective medical treatment for PAD when physicians in several countries
completed placements of a CE Mark approved DES designed specifically to treat
severe blockages in one of the largest arteries in the leg. Following the
evaluation of more than 1,200 patients worldwide during its development, the
Zilver PTX stent received CE Mark approval on July 24, 2009 and the first
commercial implantations of the device were conducted today in a coordinated
effort by physicians in the United Kingdom, Germany, France, Holland, Belgium,
Sweden and Spain.
    The Zilver PTX is specifically designed and CE Mark approved to treat PAD
affecting the main blood vessel in the thigh, the superficial femoral artery
(SFA). It is a self-expanding stent made of nitinol, a space-age 'shape
memory' metal that offers unique mechanical advantages for a stent implanted
in the SFA, such as the ability to resist kinking or fracturing as a result of
normal movement of the leg. In addition, the Zilver PTX provides targeted
delivery of paclitaxel, a drug proven to reduce restenosis, the re-narrowing
of the artery with scar tissue resulting from the trauma of opening the vessel
by balloon angioplasty. Originally discovered by Angiotech and licensed to
Cook Medical for peripheral artery disease (and other indications) and to
Boston Scientific Corporation (BSC) for coronary artery disease (and other
indications), Angiotech's paclitaxel technology has been successfully and
safely used in millions of patients suffering from coronary artery disease as
part of BSC's TAXUS paclitaxel-eluting coronary stent program. As a result of
these combined attributes, the clinical trial results suggest that the Zilver
PTX stent is a durable and clinically effective peripheral stent that also has
an excellent patient safety profile.
    The granting of the CE Mark follows the largest clinical evaluation ever
conducted for a peripheral vascular DES, led by Dr. Dake. As reported by Cook,
the Zilver PTX registry involved 791 patients from Europe, Russia, Canada and
Korea and demonstrated highly positive results. Failure rates for the device
were very low, with only 8 percent of patients with de novo (new) lesions
requiring a re-intervention to reopen the artery within the first 12 months -
a rate significantly surpassing existing treatments for PAD in the SFA, such
as balloon angioplasty and bare metal (non-drug-eluting) stents. Also,
specific patient groups that are often difficult to treat, such as diabetics
and patients with in-stent restenosis (i.e. patients whose previously placed
bare metal stent had become blocked by scar tissue), were shown in the trial
to benefit from the Zilver PTX. Importantly, the trial data indicates that the
positive results achieved in the first year after treatment are largely
maintained through the second year (24 months), an important clinical

    About Peripheral Arterial Disease (PAD)

    PAD is one of the fastest-growing and most pervasive diseases of our
time, and it is estimated to affect 27 million individuals in Europe and North
America.(1),(2),(3) Physical symptoms are only present in approximately one
third of these individuals.(1),(4),(5) The 'silent' nature of this condition
results in a significant number of patients being diagnosed only after their
disease has progressed to a severe stage. Symptomatic PAD initially results in
intermittent claudication (IC).(6) IC is characterized by muscle pain or
fatigue in the legs that occurs during exercise and is relieved by a short
period of rest. Further disease progression can result in critical limb
ischemia (CLI)(6),(7), a severe condition associated with chronic pain, ulcers
or gangrene due to severe arterial occlusion. In many countries, untreated PAD
is the leading cause of leg amputation. Approximately 120,000 to 400,000 leg
amputations occur annually due to PAD.(6),(7) Even when treated, current
therapies such as bypass surgery and balloon angioplasty(8) are either much
more invasive or have shown only limited long-term success rates. PAD, either
directly or indirectly, results in a high mortality rate; only 30% of patients
are still alive 15 years after initial diagnosis with the disease(4).

    The peripheral vascular stent market is estimated to be $200 million in
Europe and $1 billion worldwide, with approximately 1/3 of these procedures
occurring in the lower limbs. There were approximately 140,000 bypass
surgeries performed to treat blockages of the Superficial Femoral Artery in
the European Union in 2008 and 200,000 of these surgeries in the United

    The Zilver PTX drug-eluting stent is an investigational device not
available in the United States.

    Forward Looking Statements

    Statements contained in this press release that are not based on
historical fact, including without limitation statements containing the words
"believes," "may," "plans," "will," "estimates," "continues," "anticipates,"
"intends," "expects" and similar expressions, constitute "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act
of 1995 and constitute "forward-looking information" within the meaning of
applicable Canadian securities laws. All such statements are made pursuant to
the "safe harbor" provisions of applicable securities legislation.
Forward-looking statements may involve, but are not limited to, comments with
respect to our objectives and priorities for the remainder of 2009 and beyond,
our strategies or future actions, our targets, expectations for our financial
condition and the results of, or outlook for, our operations, research and
development and product and drug development. Such forward-looking statements
involve known and unknown risks, uncertainties and other factors that may
cause the actual results, events or developments to be materially different
from any future results, events or developments expressed or implied by such
forward-looking statements. Many such known risks, uncertainties and other
factors are taken into account as part of our assumptions underlying these
forward-looking statements and include, among others, the following: general
economic and business conditions in the United States, Canada and the other
regions in which we operate; market demand; technological changes that could
impact our existing products or our ability to develop and commercialize
future products; competition; existing governmental regulations and changes
in, or the failure to comply with, governmental regulations; availability of
financial reimbursement coverage from governmental and third-party payers for
products and related treatments; adverse results or unexpected delays in
pre-clinical and clinical product development processes; adverse findings
related to the safety and/or efficacy of our products or products sold by our
partners; decisions, and the timing of decisions, made by health regulatory
agencies regarding approval of our technology and products; the requirement
for substantial funding to conduct research and development, to expand
manufacturing and commercialization activities; and any other factors that may
affect our performance. In addition, our business is subject to certain
operating risks that may cause any results expressed or implied by the
forward-looking statements in this Quarterly Report on Form 10-Q to differ
materially from our actual results. These operating risks include: our ability
to attract and retain qualified personnel; our ability to successfully
complete pre-clinical and clinical development of our products; changes in our
business strategy or development plans; our failure to obtain patent
protection for discoveries; loss of patent protection resulting from
third-party challenges to our patents; commercialization limitations imposed
by patents owned or controlled by third parties; our ability to obtain rights
to technology from licensors; liability for patent claims and other claims
asserted against us; our ability to obtain and enforce timely patent and other
intellectual property protection for our technology and products; the ability
to enter into, and to maintain, corporate alliances relating to the
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manufacture, market and sell our products; the availability of capital to
finance our activities; our ability to restructure and to service our debt
obligations; and any other factors referenced in our other filings with the
applicable Canadian securities regulatory authorities or the Securities and
Exchange Commission ("SEC"). For a more thorough discussion of the risks
associated with our business, see the "Risk Factors" section in our annual
report for the year ended December 31, 2008 filed with the SEC on Form 10-K,
and our quarterly report for the three months ended June 30, 2009 filed with
the SEC on Form 10-Q.
    Given these uncertainties, assumptions and risk factors, investors are
cautioned not to place undue reliance on such forward-looking statements.
Except as required by law, we disclaim any obligation to update any such
factors or to publicly announce the result of any revisions to any of the
forward-looking statements contained in this press release to reflect future
results, events or developments.

    (C)2009 Angiotech Pharmaceuticals, Inc. All Rights Reserved.

    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:   ANPI, TSX: ANP),
please visit our website at

    About Cook Medical:

    Cook Medical was one of the first companies to help popularise
interventional medicine, pioneering many of the devices now commonly used
worldwide to perform minimally invasive medical procedures. Today, the company
integrates device design, biopharma, gene and cell therapy, and biotech to
enhance patient safety and improve clinical outcomes in the fields of aortic
intervention; interventional cardiology; critical care medicine;
gastroenterology; radiology, peripheral vascular, bone access and oncology;
surgery and soft-tissue repair; urology; and assisted reproductive technology,
gynaecology and high-risk obstetrics. Cook is a past winner of the prestigious
Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic
Industry magazine. For more information, visit

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    (2) Golomb BA, Dang TT, Criqui MH, et al. Peripheral arterial disease:
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    (3) Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA 2005 guidelines for
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    (5) Selvin E, Erlinger TP. Prevalence of and risk factors for peripheral
        arterial disease in the United States: results from the National
        Health and Nutrition Examination Survey, 1999-2000.
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    (6) Norgren L, Hiatt WR, et al. Inter-Society Consensus for the
        Management of Peripheral Arterial Disease (TASC II). Available at: Accessed October 2007.(*)
    (7) Jaccard Y, et al. Influence of secondary infection on amputation in
        chronic critical limb ischemia. Eur J Vasc Endovasc Surg 2007; 33(5):

For further information:

For further information: DeDe Sheel, Investor Relations and Corporate
Communications, Angiotech Pharmaceuticals, Inc., (415) 293-4412,

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