Conor Medsystems Announces Two-Year Follow-Up Data from EuroSTAR Pivotal Study
05 Septiembre 2006 - 9:00AM
PR Newswire (US)
Results Demonstrate Long-term Safety and Efficacy of the CoStar(R)
Cobalt Chromium Paclitaxel-Eluting Coronary Stent MENLO PARK,
Calif., Sept. 5 /PRNewswire-FirstCall/ -- Conor Medsystems, Inc.
(NASDAQ:CONR), a developer of innovative, controlled vascular drug
delivery technologies, today announced two-year follow-up clinical
data from the first arm of its pivotal EuroSTAR study single- and
multi-vessel coronary artery disease. The clinical results are
being presented today by Keith D. Dawkins, M.D., FRCP, FACC,
Director of Cardiac Interventions at Southampton University
Hospital, Southampton, United Kingdom, at the European Society of
Cardiology/World Congress of Cardiology 2006 in Barcelona, Spain.
"There were low rates of clinical events through 24 months,
demonstrating the stability of outcomes with the CoStar stent,"
said Dr. Dawkins. "With its low profile and high radiopacity, the
CoStar stent is highly deliverable. In addition, the use of
bioresorbable polymers ensures that no permanent polymer residue or
drug remains at the target site, which may confer a long-term
advantage with respect to reduced rates of late stent thrombosis."
A total of 176 lesions were treated in 145 patients using the
CoStar stent formulated to release a therapeutic dose of 10mcg of
paclitaxel per 17mm stent over approximately 30 days (based on in
vitro measurements). At 24-month follow-up, the target lesion
revascularization rate was 3.6 percent, compared to 2.8 percent at
12-month follow-up, and the cumulative major adverse cardiac event
rate was 10.4 percent, compared to 8.3 percent at 12-month
follow-up. There were no reported cases of stent thrombosis between
the cessation of anti-platelet therapy at six months and 24-month
follow-up. "We are very pleased with the consistent clinical
results for the CoStar stent, which after two years continues to
demonstrate a positive safety and efficacy profile," said Azin
Parhizgar, Ph.D., Chief Operating Officer of Conor. "A low-dose,
long-release formulation of paclitaxel from a bioresorbable polymer
proved to be efficacious over the long-term. The rate of adverse
clinical events from six months to 24 months was very low in this
population of patients with chronic ischemic heart disease." In
contrast to conventional surface-coated stents, Conor's stents have
been specifically designed for vascular drug delivery. Conor's
CoStar stent incorporates hundreds of small holes, each acting as a
reservoir into which drug-polymer compositions can be loaded. In
addition, the CoStar stent uses bioresorbable polymers that are
absorbed by the body after the drug is released, leaving no
permanent residual polymers at the target site. The CoStar stent is
not available for sale in the United States where it is an
investigational device limited by law to investigational use. About
Conor Medsystems Conor Medsystems, Inc. develops innovative
controlled vascular drug delivery technologies, and has primarily
focused on the development of drug eluting stents to treat coronary
artery disease. For further information on Conor Medsystems and
controlled vascular delivery, visit http://www.conormed.com/.
Except for the historical information contained herein, this press
release contains certain forward-looking statements that involve
risks and uncertainties, including without limitation the
statements related to clinical development of the CoStar stent. All
forward-looking statements and other information included in this
press release are based on information available to Conor
Medsystems as of the date hereof, and the company assumes no
obligation to update any such forward-looking statements or
information. The company's actual results could differ materially
from those described in the company's forward-looking statements.
Factors that could cause or contribute to such differences include,
but are not limited to, those discussed in detail under "Item 1A.
Risk Factors" in the company's Quarterly Report on Form 10-Q for
the quarter ended June 30, 2006, filed with the SEC on August 9,
2006, including (i) risks related to the uncertain, lengthy and
expensive clinical development process, including, among other
things, (a) the risk that clinical results reported to date may not
be indicative of future clinical results and that the results the
company obtains with its CoStar stent in the company's U.S. pivotal
clinical trial may not show similar effectiveness, and (b) the risk
that the company's stents may not demonstrate a long-term advantage
with respect to reduced rates of late stent thrombosis; and (ii)
risks related to patent infringement, including, among other
things, (a) the risk that if any patent infringement claims or
other intellectual property claims against the company are
successful, the company may, among other things (1) be enjoined
from, or required to cease, the development, manufacture, use and
sale of products that infringe the patent rights of others, (2) be
required to expend significant resources to redesign its technology
so that it does not infringe others' patent rights, or to develop
or acquire non-infringing intellectual property, which may not be
possible, and/or (3) be required to obtain licenses to the
infringed intellectual property, which may not be available to the
company on acceptable terms, or at all, and (b) the risk that
intellectual property litigation against the company could
significantly disrupt the company's development and
commercialization efforts, divert management's attention and
quickly consume the company's financial resources. The risks and
other factors discussed above should be considered only in
connection with the fully discussed risks and other factors
discussed in detail in the company's periodic reports filed with
the SEC, including the company's Quarterly Report on Form 10-Q for
the quarter ended June 30, 2006, filed with the SEC on August 9,
2006. DATASOURCE: Conor Medsystems, Inc. CONTACT: Investor
inquiries: Michael Boennighausen, Chief Financial Officer of Conor
Medsystems, Inc., +1-650-614-4100; or, Media inquiries: BCC
Partners, Karen L. Bergman, +1-650-575-1509, or Nan Foster,
+1-415-307-6955, for Conor Medsystems, Inc. Web site:
http://www.conormed.com/
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