WASHINGTON and MENLO PARK, Calif., Oct. 13 /PRNewswire-FirstCall/ --
XTENT, Inc. (Nasdaq: XTNT) today announced positive long-term follow-up data
from the CUSTOM I, II and III clinical trials that reinforces the efficacy of
the Custom NX(R) drug eluting stent (DES) system in treating patients with
coronary artery disease. The CUSTOM clinical trials are prospective studies
designed to investigate the safety and efficacy of the Custom NX DES system.
The three trials have enrolled 220 patients and represent one of the most
challenging patient populations -- those with long and/or multiple lesions --
ever studied in DES trials.
"We are pleased to see favorable outcome trend data continue with the
CUSTOM Trials even as we look out as far as two and three years of follow-up
in very complex patients," commented Pieter R. Stella, MD, Director,
Cardiovascular Research, University Medical Centre Utrecht, The Netherlands,
and one of the CUSTOM clinical trial investigators, who presented the data
during a DES panel at the Cardiovascular Research Foundation's (CRF) twentieth
annual Transcatheter Cardiovascular Therapeutics (TCT) meeting. "To date, the
incidence of late stent thrombosis in all three CUSTOM trials is zero percent
and this is particularly encouraging."
The results presented today include three-year follow-up data from 30
patients studied in CUSTOM I, two-year data from the 100 patients in CUSTOM II
and one-year data in 90 patients enrolled in CUSTOM III. Patients enrolled in
these trials presented with the smallest reference vessel diameter (RVD) ever
in a DES study, and CUSTOM II featured the longest average lesion length ever
in a DES study.
"These long-term safety data continue to support XTENT's development of
Custom NX as the true next-generation drug eluting stent, particularly because
the ability to customize care to the individual allows us to treat patients
with long lesions and multi-vessel disease who are not well-served by
currently available technology," said Gregory D. Casciaro, XTENT's President
and CEO.
Custom NX is designed to enable a more personalized approach to the
treatment of arterial disease based on each patient's individual lesion
characteristics. The Custom NX delivery system allows physicians to customize
the length and diameter of the stent at the site of the lesion by enabling
separation at each six-mm segment and allowing for the placement of up to 60
mm of stent. The stent is coated with Biolimus A9 and PLA, a biodegradable
drug carrier.
The Custom NX DES System has not been approved for sale by any regulatory
authority.
About XTENT
XTENT, Inc. is a medical device company focused on developing and
commercializing innovative customizable drug eluting stent (DES) systems for
the treatment of coronary artery disease (CAD). CAD is the most common form
of cardiovascular disease and the number one cause of death in the United
States and Europe. XTENT(R) Custom NX(R) DES Systems are designed to enable
the treatment of single lesions, long lesions and multiple lesions of varying
lengths and diameters, in one or more arteries with a single device.
Forward Looking Statements
This press release contains forward-looking statements within the meaning
of the U.S. Private Securities Litigation Reform Act of 1995. Statements in
this press release regarding XTENT's business that are not historical facts
may be "forward-looking statements" that involve risks and uncertainties.
Specifically, these statements include, but are not limited to those
concerning: XTENT's expectations with respect to the timing of regulatory
approval or commercialization of its products, regulatory approval of XTENT's
products for treatment of long lesions, the timing of the release of its
clinical trial data. Forward-looking statements are based on management's
current, preliminary expectations, and are subject to risks and uncertainties
that could cause actual results to differ from the results predicted and which
are included in the "Risk Factors" section of XTENT's quarterly report on Form
10-Q for the quarter ended June 30, 2008. This quarterly report was filed
with the SEC on August 12, 2008, and is available on the company's investor
relations website at http://www.xtentinc.com and on the SEC's website at
http://www.sec.gov. Undue reliance should not be placed on forward-looking
statements, which speak only as of the date they are made. XTENT undertakes
no obligation to update publicly any forward-looking statements to reflect new
information, events or circumstances after the date they were made, or to
reflect the occurrence of unanticipated events.
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