Healthcare Industry News: Liberte
News Release - October 18, 2006
Boston Scientific to Highlight Broad Range of Clinical Trial Results Reinforcing Safety and Efficacy of TAXUS(R) Coronary Stent Systems at TCT 2006
Results to include new data on next-generation TAXUS(R) Liberte(TM) Stent SystemNATICK, Mass., Oct. 18 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today announced the schedule of the Company's major events and press announcements at the Cardiovascular Research Foundation's (CRF) eighteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, which runs from October 22 to 27 in Washington, D.C.
Boston Scientific will be announcing safety and efficacy data on its next-generation TAXUS® Liberte(TM) Paclitaxel-Eluting Stent System, including one-year results from the ATLAS clinical trial and OLYMPIA "real-world" registry. In addition, the Company will present long-term data from the TAXUS I, II, IV, V de novo, V ISR, and VI clinical trials. Together, these trials and registries will study more than 31,000 patients.
"The extensive body of data we plan to present at TCT will continue to reinforce the strengths that make the TAXUS Stent the leader in the worldwide drug-eluting stent (DES) market: safety, efficacy and deliverability," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "We are very pleased that our market-leading TAXUS Express2(TM) Stent and next-generation TAXUS Liberte Stent will now be joined by an Everolimus-based DES -- PROMUS(TM) -- making us the only company to offer two distinct drug platforms." (PROMUS is a private-labeled XIENCE(TM) V Everolimus-Eluting Coronary Stent System manufactured by Abbott Vascular and distributed by Boston Scientific.)
"We will also address the issue of late stent thrombosis and highlight the safety of the TAXUS Express2 Stent system through a four-year meta-analysis on 3,500 patients," added LaViolette. "Our data clearly demonstrate the overall benefits of the TAXUS Express2 Stent versus bare-metal stents, with no increase in death or heart attack in TAXUS Express2."
Schedule of Events
Monday, October 23 (all times are ET)
* BEACH Trial Results on Carotid Stenting. At 4:45 p.m., two-year
follow-up results from the BEACH clinical trial will be presented in an
oral abstract session by Michael Jaff, D.O., in Room 145AB. BEACH is a
prospective, single-arm, multi-center trial designed to evaluate the
safety and efficacy of the Company's Monorail® Carotid WALLSTENT®
Endoprosthesis in conjunction with the FilterWire EX® and FilterWire
EZ(TM) Embolic Protection Systems in the treatment of high-risk patients
with carotid artery disease. The Company will issue a press release at
this time.
* TC-WYRE Clinical Trial Data. One-year results from the TC-WYRE study
will be presented in a poster session by David Kandzari, M.D. TC-WYRE
(TAXUS Cypher -- What's Your Real World Experience) is a multi-center
comparison of TAXUS Express2 and Cypher® stents in more than 1,500
patients in the U.S. The Company will issue a press release at this
time.
* Symposium on Drug-Eluting Stents. From 8:00 - 10:00 p.m., the Company
will host a symposium entitled "The Next Generation DES: Are We There
Yet?" chaired by Gregg Stone, M.D., in the Grand Ballroom of the
Renaissance Hotel. The symposium will include a review of the latest
clinical evidence from the four-year TAXUS Stent meta-analysis by Dr.
Stone; a panel discussion moderated by Boston Scientific's Chief Medical
and Scientific Officer, Donald Baim, M.D., with case presentations
reviewing safety records of the TAXUS Stent and Cypher drug-eluting
stents; an update on the latest clinical data on TAXUS Liberte by Mark
Turco, M.D., F.A.C.C.; and a review of the Company's future DES
pipeline, including the ODYSSEY program presented by Martin Leon, M.D.
A reception will be held prior to the symposium at 7:00 p.m.
Tuesday, October 24
* TAXUS Meta-Analysis. Results from the four-year TAXUS Stent
meta-analysis will be presented during a special "Stent Thrombosis Hot
Line" session entitled "From Hard Data to Practical Recommendations,"
which will take place from 12:45-1:45 p.m. in the Coronary Theater. The
issue of stent thrombosis and the safety of drug-eluting stents will be
addressed through physician-directed clinical trial meta-analyses. The
session will conclude with a roundtable discussion on balancing the
safety and efficacy of drug-eluting stents moderated by Dr. Leon and Dr.
Stone, which will feature several prominent industry representatives
including Dr. Baim.
Wednesday, October 25
* TAXUS OLYMPIA Registry. At 12:30 p.m., updates from the TAXUS OLYMPIA
registry will be presented by Martyn Thomas, M.D., at a "First Report"
session in the main arena. Dr. Thomas will provide an analysis of
twelve-month results from Phase I patients and six-month results from
the first 2,000 patients in Phase III of the prospective, multi-center,
multi-phased registry. OLYMPIA is designed to analyze real-world
clinical outcomes data for Boston Scientific's next-generation TAXUS
Liberte Paclitaxel-Eluting Stent System. The global registry has a
planned enrollment of up to 27,000 patients, making it the largest study
of its kind worldwide. The Company will issue a press release at this
time.
* TAXUS ATLAS Workhorse and Direct Stenting Results. At 12:45 p.m., Dr.
Turco will present clinical and angiographic results from the TAXUS
ATLAS clinical trial at a "First Report" session in the main arena.
Dr. Turco, the study's co-principal investigator, will present 12-month
workhorse and nine-month direct stenting data. The ATLAS clinical trial
is a global, multi-center, pivotal study designed to support U.S. Food
and Drug Administration approval of TAXUS Liberte and is the first
global trial of a second-generation DES. The Company will issue a press
release at this time.
* Analyst Meeting. At 1:30 p.m., the Company will host an analyst meeting
in the Grand Ballroom of the Renaissance Hotel. The meeting is open to
the media and will include a DES clinical program update by Dr. Baim and
a DES business update by Paul LaViolette. This meeting is being webcast
and can be accessed at Boston Scientific's website,
http://www.bostonscientific.com. Please visit the website for details
on how to access the webcast. A replay of the webcast will be archived
and available in the Webcast and Archives section of the Investor
Relations site at http://www.bostonscientific.com.
* Symposium on Carotid Artery Stenting (CAS). From 8:00 - 10:00 p.m., the
Company will host a symposium entitled "Carotid Artery Stenting:
Defining the Frontier" chaired by Christopher White, M.D., in the Grand
Ballroom of the Renaissance Hotel. The symposium will include
presentations on future trends and innovations in CAS, a review of open
versus closed cell stent technology, and a panel discussion addressing
the challenges of CAS practice. Participants will include Alberto
Cremonesi, M.D., Subbarao Mylavarapu, M.D., Kenneth Ouriel, M.D., and
Barry Katzen, M.D. A reception will be held prior to the symposium at
7:00 p.m.
Other TAXUS Data Presentations
The Company will announce the following safety and efficacy data from its comprehensive TAXUS clinical trial program, which will be presented as additional oral abstracts or posters at TCT. The Company will issue a press release summarizing data from all clinical trials following the conference.
* TAXUS I first five-year clinical follow-up from a randomized DES trial
(poster session by Dr. Eberhard Grube, et al.)
* TAXUS II four-year clinical follow-up (oral abstract session by Dr.
Antonio Colombo, et al. at 5:00 p.m. on Wednesday Oct. 25)
* TAXUS IV four-year clinical outcomes (oral abstract session by Dr. James
Hermiller, et al. at 2:00 p.m. on Tuesday Oct. 24)
* TAXUS V De Novo lesions two-year clinical data (poster session by Dr.
Stephen Ellis, et al.)
* TAXUS V ISR (In-Stent Restenosis) one-year clinical data (poster session
by Dr. Stephen Ellis, et al.)
* TAXUS VI three-year outcomes in high-risk subgroups (poster session by
Dr. Keith Dawkins, et al.)
Boston Scientific will present its latest innovations at booth 1245 in the Exhibition hall. Key product demonstrations will include a hands-on deliverability zone, medical simulation sessions, live case viewing, and new technology displays, including the LATITUDE® Patient Management System and the iLab(TM) Ultrasound Imaging System. Members of the Company's Executive Committee will also be available during specified exhibit hours.
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: http://www.bostonscientific.com.
This press release contains forward-looking statements. The Company 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 clinical trials, the regulatory approval process, reimbursement policies, commercialization of new technologies, litigation, the Company's overall business strategy and other factors described in the Company's filings with the Securities and Exchange Commission.
Source: Boston Scientific
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