Angiotech partner first to receive FDA approval allowing immediate MRI exams for its TAXUS(R) Express(2)(TM) paclitaxel-eluting
05 April 2005 - 4:05PM
PR Newswire (US)
Angiotech partner first to receive FDA approval allowing immediate
MRI exams for its TAXUS(R) Express(2)(TM) paclitaxel-eluting stent
system Typical two-month wait eliminated for patients with Boston
Scientific stent systems VANCOUVER, April 5 /PRNewswire-FirstCall/
-- Angiotech Pharmaceuticals, Inc.
(NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP) corporate partner Boston
Scientific Corporation ("Boston") today announced that the U.S.
Food and Drug Administration (FDA) has approved enhancements to the
Directions for Use (DFU) of the TAXUS(R) Express(2)(TM)
paclitaxel-eluting coronary stent system, indicating that patients
receiving the stent systems may safely undergo Magnetic Resonance
Imaging (MRI) examination immediately following implantation. The
TAXUS stent system is the first drug-eluting stent to receive
approval for immediate post-procedure MRI. Boston Scientific's
Express(2) (bare-metal) stent system also received approval for
immediate MRI exams. Patients receiving coronary stents have
typically been required to wait approximately two months before
receiving an MRI. MRI is an effective method of providing detailed
diagnosis for many types of injuries and conditions, including
cardiovascular disease. Due to the use of intense magnetic fields
in MRI examinations, implanted medical devices that contain metal
may be subject to potential migration and heating within the body.
As a result, DFUs for stent systems containing metal usually
recommend a waiting period of approximately two months from the
time of implantation until an MRI can be performed safely. Boston
Scientific performed rigorous laboratory testing to demonstrate MRI
compatibility. The TAXUS Express(2) and Express(2) systems were
shown to be MRI safe at a high level of magnetic field strengths
with minimal effect on temperature rise and drug release. "The FDA
approval of the timing on MRI exams is a significant development
for interventional cardiologists and their patients," said Paul
LaViolette, Boston Scientific Chief Operating Officer. "Patients
undergoing stent procedures can now avoid the long waiting period
previously required before receiving MRI diagnostics during the
most critical stage of their recovery. With our stent systems, MRI
analyses can now be performed immediately." Physicians interested
in reviewing a complete copy of the revised TAXUS Express(2) stent
DFU may obtain a copy from the TAXUS website at
http://www.taxus-stent.com/. The revised Express(2) bare-metal
stent DFU will be available shortly. BSC acquired worldwide
exclusive rights from Angiotech to use paclitaxel to coat its
coronary stent products and has co-exclusive rights to other
vascular and non-vascular products. Vancouver-based Angiotech
Pharmaceuticals, Inc. is a specialty pharmaceutical company
pioneering the combination of pharmaceutical compounds with medical
devices and biomaterials to both create novel solutions for poorly
addressed disease states and dramatically improve surgical
outcomes. To find out more about Angiotech Pharmaceuticals, Inc.
(NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), please visit our website at
http://www.angiotech.com/. Statements contained herein that are not
based on historical or current fact, including without limitation
statements containing the words "anticipates," "believes," "may,"
"continue," "estimate," "expects," "may" and "will" and words of
similar import, constitute "forward-looking statements" within the
meaning of the U.S. Private Securities Litigation Reform Act of
1995. 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. Such factors include, among others, the
following: general economic and business conditions, both
nationally and in the regions in which the Company operates;
technology changes; competition; changes in business strategy or
development plans; the ability to attract and retain qualified
personnel; existing governmental regulations and changes in, or the
failure to comply with, governmental regulations; liability and
other claims asserted against the Company; and other factors
referenced in the Company's filings with the United States
Securities and Exchange Commission or the Canadian securities
regulators. Given these uncertainties, readers are cautioned not to
place undue reliance on such forward-looking statements. The
Company does not assume the obligation to update any
forward-looking statements. CONTACTS: Todd Young, Angiotech
Pharmaceuticals, Inc. (Analysts & Investors) (604) 221-7676 ext
6933 Rui Avelar, Angiotech Pharmaceuticals, Inc. (Analysts) (604)
221-7676 ext 6996 Eric Starkman, Starkman & Associates (Media)
(212) 252-8545 ext 12 DATASOURCE: Angiotech Pharmaceuticals, Inc.
CONTACT: Todd Young, Angiotech Pharmaceuticals, Inc. (Analysts
& Investors), (604) 221-7676 ext 6933; Rui Avelar, Angiotech
Pharmaceuticals, Inc. (Analysts), (604) 221-7676 ext 6996; Eric
Starkman, Starkman & Associates (Media), (212) 252-8545 ext 12
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