MEDIA RELEASE PR37555
Boston Scientific Announces Completion of Enrollment in Aneurysm Coiling Clinical
Trial
NATICK, Mass., Jan. 5 /PRNewswire-AsiaNet/ --
Boston Scientific Corporation (NYSE: BSX) today announced that it has
completed enrollment in its MAPS(TM) clinical trial, which is studying the
coiling of intracranial aneurysms. This prospective, randomized trial
commenced enrollment in 2007 and has reached its goal of 630 patients,
enrolled at 47 hospitals in 11 countries. Principal investigators for the
trial are Anil Gholkar, O.B.E., M.B.B.S., Clay Johnston, M.D., Ph.D., and
Cameron McDougall, M.D.
The MAPS trial compares clinical outcomes in patients treated with either
bare-platinum GDC(R) Detachable Coils or Matrix2(R) Detachable Coils, which
are covered with a bio-polymer. The primary endpoint is Target Aneurysm
Recurrence (TAR) at one year, a composite clinical endpoint of target
aneurysm rupture or re-rupture, re-treatment or neurologic death. Secondary
angiographic endpoints will be compared to the primary clinical outcomes over
several years to evaluate the long-term predictive value of 12-month
angiography.
"The MAPS trial has significant potential to enhance our understanding of
the products we use to treat intracranial aneurysms as well as our methods
for assessing outcomes," said Dr. Gholkar. "By conducting rigorous
measurement, monitoring and adjudication of clinical outcomes over multiple
years, the MAPS trial will establish a critical baseline from which to judge
existing treatments as well as future endovascular technologies."
Aquilla Turk, D.O., is the Chairman of the MAPS Steering Committee and
enrolled the final patient in the trial. "With enrollment completed, our
focus now turns to data monitoring, completion of follow up and preparation
for primary endpoint publication in 2011," said Dr. Turk. "The Steering
Committee is grateful to all the trial investigators who have worked so
diligently to reach this milestone."
"This important trial is the latest example of Boston Scientific's 24
years of collaboration and leadership in the field of neurointervention and
lays the groundwork for continued advances in the minimally invasive
treatment of brain aneurysms," said Mark Paul, President of Boston
Scientific's Neurovascular business. "We appreciate the participation of the
124 physicians and 63 research coordinators, whose efforts led to the
successful completion of enrollment."
For more information on the MAPS Trial visit:
Boston Scientific is a worldwide developer, manufacturer and marketer of
medical devices whose products are used in a broad range of interventional
medical specialties. For more information, please visit:
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements. Boston Scientific
wishes to caution the reader of this press release that actual results may
differ from those discussed in the forward-looking statements and may be
adversely affected by, among other things, risks associated with new product
development and commercialization, clinical trials, intellectual property,
regulatory approvals, competitive offerings, Boston Scientific's overall
business strategy, and other factors described in Boston Scientific's filings
with the Securities and Exchange Commission.
CONTACT: Geraldine Varoqui
Boston Scientific
Public Relations International
+49 170 782 85 58
varoquig@bsci.com
SOURCE: Boston Scientific Corporation
CONTACT: Geraldine Varoqui,
Boston Scientific,
Public Relations International,
+49-170-782-85-58,
varoquig@bsci.com
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