Angiotech Pharmaceuticals announces FDA 510(k) clearance of the Option(TM) Inferior Vena Cava Filter
08 Juni 2009 - 2:30PM
PR Newswire (US)
VANCOUVER, June 8 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ: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:ANPINASDAQ:TSX:NASDAQ:ANP), please visit our website at
http://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. DATASOURCE: Angiotech Pharmaceuticals, Inc.
CONTACT: DeDe Sheel, Investor Relations and Corporate
Communications, Angiotech Pharmaceuticals, Inc., (415) 293-4412,
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