MENLO PARK, Calif., Aug. 26 CA-XTNT-CUSTOM-II-Dat
MENLO PARK, Calif., Aug. 26 /PRNewswire-FirstCall/ -- XTENT, Inc.
(Nasdaq: XTNT) today announced that the positive one-year follow-up data from
the CUSTOM II trial was published in the most recent issue of the
peer-reviewed journal, EuroIntervention. The lead author of the article was
Dr. Pieter R. Stella, M.D., of University Medical Center Utrecht, Utrecht, The
Netherlands on behalf of the CUSTOM II Investigators from 13 clinical sites
across Europe.
The one-year CUSTOM II trial, a single-arm, 100-patient prospective study
designed to evaluate the safety and efficacy of XTENT's Custom NX(R)
drug-eluting stent (DES) system in patients with coronary artery disease,
showed no new major adverse cardiac events (MACE) since the first analysis was
performed at six months. The incidence of late stent thrombosis for patients
treated with Custom NX in the study was zero percent.
CUSTOM II one-year follow-up results were first presented last year at
Cardiovascular Research Foundation's (CRF) nineteenth annual Transcatheter
Cardiovascular Therapeutics (TCT) meeting.
"This article marks our second publication of Custom NX data in this
prestigious peer-reviewed journal this year," said Gregory D. Casciaro,
XTENT's president and CEO. "We have been extremely pleased with the safety
and efficacy Custom NX has demonstrated in the CUSTOM I, II and III trials,
and appreciate the level of interest and support our technology continues to
receive from the clinical community."
Results from the two-year follow-up of CUSTOM I, a 30-patient first-in-man
study designed to evaluate the preliminary safety and feasibility of in-situ
stent customization, were also published in EuroIntervention earlier this
year. This study showed no new major adverse cardiac events (MACE) were
reported since the one-year analysis, and the incidence of late stent
thrombosis for patients treated with Custom NX was zero percent. The CUSTOM I
article published in EuroIntervention was recognized by the journal's
editorial board as one of the six best papers submitted to the journal during
the previous winter, and Lutz Buellesfeld, M.D., of the HELIOS Heart Center in
Siegburg, Germany, received an award in conjunction with the publication after
presenting it at the annual EuroPCR meeting in May.
The CUSTOM II trial was designed to evaluate the safety and efficacy of
Custom NX for the treatment of long and multiple lesions. Of the 100 patients
enrolled, 69 patients were enrolled in the long-lesion arm, and 31 patients
were enrolled in the two-lesion arm of the study. CUSTOM II enrolled one of
the most difficult to treat patient populations ever studied in a DES trial.
In the CUSTOM II patient population, the average vessel diameter was 2.57mm
and the average lesion length was 28.7mm. Twenty-six percent of the study
participants were diabetic. The percentage of patients with ACC/AHA lesion
grade B2 or C was 65.1 percent. CUSTOM II's six-month clinical results have
been sustained at one year. The target lesion revascularization rate remained
constant at four percent, with no new MACE events, and no late stent
thrombosis.
The EuroIntervention paper, titled "One year results of a new in-situ
length-adjustable stent platform with a biodegradable Biolimus A9 eluting
polymer: result of the CUSTOM-II trial," can be accessed at:
http://www.europcronline.com/eurointervention/15th_issue/37/.
About the Custom NX(R) DES System
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 system allows physicians to customize the
length and diameter of the stent at the site of the lesion. The system
features a proprietary modular stent design that consists of multiple 6mm
cobalt chromium segments coated with Biolimus A9(R) and PLA, a biodegradable
drug carrier. The Custom NX delivery system enables the stent length to be
adjusted in 6mm increments and allows for the placement of up to 60mm of stent
at one or more locations. 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.
Note: XTENT(R) Custom NX(R) DES Systems have not been approved for sale by
any regulatory authority.
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: the performance of XTENT's DES Systems or the results of future
clinical trials. 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 most recent 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.
SOURCE XTENT, Inc.
