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XTENT Announces Positive Two-Year CUSTOM I and One-Year CUSTOM II Trial Data for Novel Drug-Eluting Stent System
Date:10/22/2007

No New MACE, Zero Late Stent Thrombosis - Company Also Provides Clinical Program Update and Will Host Webcast Mon.,

Oct. 22 at 7:00 a.m. ET -

WASHINGTON, Oct. 22 /PRNewswire-FirstCall/ -- XTENT, Inc. (Nasdaq: XTNT) today announced positive long-term follow-up data from the CUSTOM I and CUSTOM II single-arm prospective studies evaluating the safety and efficacy of its Custom NX(R) drug-eluting stent system in patients with coronary artery disease.

At one-year CUSTOM II clinical follow-up and at two-year CUSTOM I clinical follow-up, no new major adverse cardiac events (MACE) were reported. The incidence of late stent thrombosis for patients treated with Custom NX in both trials was zero percent.

"These long term results are exceptional. CUSTOM I and II are unlike any other early stage drug-eluting stent trial because of the lesion length and complexity of the patients treated in these trials," said Professor Eberhard Grube, M.D., chief of cardiology at the HELIOS Heart Center in Siegburg, Germany, and Principal Investigator of CUSTOM I and CUSTOM II. Professor Grube presented CUSTOM I two-year results and CUSTOM II one-year results during a satellite symposium Sunday evening at the Cardiovascular Research Foundation's (CRF) nineteenth annual Transcatheter Cardiovascular Therapeutics (TCT) meeting.

Additionally, the company announced it recently filed its Investigational Device Exemption (IDE) to begin the CUSTOM IV pivotal trial and has now received questions back from the Food and Drug Administration (FDA). "Submission of our IDE was a significant milestone for the company and allows us to have clear discussions with the agency about the requirements necessary to gain approval to start the trial and continue our progress to bring Custom NX to physicians and patients," said Gregory D. Casciaro, President and CEO of XTENT. "We are quickly mobilizing to work with the FDA and as soon as we have spec
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SOURCE XTENT, Inc.
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