Angiotech Pharmaceuticals announces FDA 510(k) clearance of the Option(TM) Inferior Vena Cava Filter



    VANCOUVER, June 8 /CNW/ - Angiotech Pharmaceuticals, Inc. (NASDAQ:   ANPI,
TSX: ANP) today announced that the U.S. Food and Drug Administration (FDA) has
granted 510(k) clearance for the Option(TM) Inferior Vena Cava (IVC) Filter in
the United States, for use in both permanent and retrievable indications.
Angiotech holds exclusive worldwide rights to market and distribute the Option
IVC Filter, which it obtained in a license agreement with privately held Rex
Medical, LP (Rex Medical), as previously announced in March 2008.
    The Option IVC Filter is used for the prevention of recurrent pulmonary
embolism (PE). The device is implanted, typically by interventional
radiologists in a minimally invasive procedure, into the body's inferior vena
cava to prevent PE. Option is specifically designed for use as both a
permanent or temporary implant (in temporary, or retrievable, indications, a
physician may later perform a second surgical procedure to remove the Option
IVC Filter if necessary or where mandated clinically).
    "This important FDA clearance of the Option IVC Filter continues
Angiotech's mission of offering the most highly innovative technology
solutions to our physician customers and their patients," said Dr. William
Hunter, President and CEO of Angiotech. "We are excited to commence commercial
sales of Option through our dedicated Interventional Sales Team in the very
near future. We believe the flexibility to use the Option IVC Filter in both
permanent and retrievable indications, with clinical study data indicating 92%
retrieval success, and a retrieval at up to 175 days post-implantation,
provides Option the opportunity to be the market leading product in PE
prevention."
    According to market analysis conducted by Millennium Research Group, the
U.S. market for IVC filters was approximately $200 million in 2007 (with
approximately 160,000 IVC filters implanted). This market is predicted to grow
to $300 million by 2012. IVC filters can be permanent or retrievable (where a
physician can remove them when the patients no longer require them).
Retrievable filters accounted for approximately two-thirds of the market in
2007. The Option IVC Filter is designed to be used in both permanent and
retrievable indications and has been successfully retrieved at long intervals
- up to 175 days post-implantation in the U.S. clinical trial.
    The results of a recently concluded clinical trial for the Option IVC
Filter were presented by the study's Principle Investigator, Dr. Matthew
Johnson, at the 34th Annual Scientific Meeting of the Society of
Interventional Radiology in March of 2009. The single-arm, multicenter
clinical trial, which enrolled 100 patients with a mean age of 59 years, was
designed to evaluate the safety and efficacy of the Option IVC filter when
used both as a permanent and temporary filter in patients at increased risk
for pulmonary embolism. In the trial, clinical success, defined as placement
technical success without subsequent PE, significant filter migration or
embolization, symptomatic thrombosis or other complications requiring filter
removal or intervention, was achieved in 88% of subjects. Retrieval success
was achieved in 92% (36/39) of cases where retrieval was attempted, with a
mean implantation time in those cases of 67 days. The safety profile of the
Option IVC Filter was consistent with other currently marketed IVC filters.

    About the Option(TM) Inferior Vena Cava Filter

    The Option IVC filter, developed by Rex Medical, is specifically designed
to facilitate long-term retrieval post device implantation if desired or
deemed necessary by the treating physician, and can be used in the following
conditions: pulmonary thromboembolism when anticoagulant therapy is
contraindicated, failure of anticoagulant therapy in thromboembolic diseases,
emergency treatment following massive PE, and chronic recurrent PE when
anticoagulant therapy has failed or is contraindicated. The nitinol,
Option(TM) IVC Filter, with a low profile delivery system, is designed with
struts which direct clot volume into the center of the vessel for maximum
dissolution and preservation of blood flow, allowing for capture of clinically
significant clot and protection against PE. The self-centering filter
facilitates optimal positioning and stability within the inferior vena cava.

    About Pulmonary Embolism (PE)

    PE is an extremely common and highly lethal condition. PE is the sudden
blocking of an artery of the lung (pulmonary artery) by a collection of solid
material brought through the bloodstream (embolus) - usually a blood clot
(thrombus) or other foreign material. PE occurs when these clots break loose
and "embolize" to block pulmonary blood vessels in the lungs. According to
clinical research, if left untreated, PE has a mortality rate of 30%. Emboli
dislodgement can be caused by peripheral vascular disease (PVD), severe deep
vein thrombosis (DVT), trauma and, prolonged immobilization often following a
major surgical procedure.

    
    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 U.S. Private Securities Litigation
Reform Act of 1995 and "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 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, development, 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 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, both nationally and in the 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; 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 and to expand
manufacturing and commercialization activities or consummate acquisitions; and
any other factors that may affect performance. In addition, our business is
subject to certain operating risks that may cause the actual results expressed
or implied by the forward-looking statements in this press release 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
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
development and commercialization of our technology and products; market
acceptance of our technology and products; our ability to successfully
manufacture, market and sell our products; the continued availability of
capital to finance our activities; and any other factors referenced in our
other filings with the Securities and Exchange Commission ("SEC") and
applicable Canadian regulatory authorities. 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 March 31, 2009 filed
with the SEC on Form 10-Q.

    Given these uncertainties, assumptions and risk factors, readers 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.

    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 www.angiotech.com.

    About Rex Medical, LP

    Rex Medical, LP, based in Conshohocken, PA, is a privately held medical
device company specializing in the development, manufacturing and marketing of
minimally invasive medical devices targeted towards the cardiovascular, venous
access, endosurgery and oncology markets.

    Option(TM) is a trademark of Rex Medical, LP, used under license by
Angiotech.





For further information:

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

Organization Profile

Angiotech Pharmaceuticals, Inc.

More on this organization


Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890