"We continue to make excellent progress in the development of our innovative stent systems," commented Gregory D. Casciaro, XTENT's President and CEO. "In October, we announced very encouraging results from our CUSTOM I and CUSTOM II clinical trials at the Transcatheter Cardiovascular Therapeutics (TCT) conference. At two year follow-up for CUSTOM I and one year follow-up for CUSTOM II, no new major adverse cardiac (MACE) events were reported. In addition, the incidence of late stent thrombosis in both trials was zero. Everyone at XTENT continues to be very focused on the execution of clinical, regulatory and product development milestones."
Third Quarter 2007 Highlights:
-- Completion of patient enrollment in the 90-patient CUSTOM III clinical
-- Appointment of Michael Eagle, former Vice President, Manufacturing, at
Eli Lilly and Company, to the Board of Directors
-- Filed an Investigational Device Exemption (IDE) application with the
United States Food and Drug Administration (FDA) to begin the CUSTOM IV
pivotal trial. As the company announced on October 22, 2007, at the
Transcatheter Cardiovascular Therapeutics meeting in Washington D.C.,
it recently received questions back from the FDA regarding the IDE
application, and it is working to address these questions which must be
resolved before the company can initiate its Custom IV pivotal trial.
Conference Call and Webcast Information
The company will not be hosting a quarterly earnings call for the third quarter of 2007 as it provided an update during its conference call and webcast at TCT on October 22, 2007.
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
|SOURCE XTENT, Inc.|
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