XTENT Announces Positive Two-Year CUSTOM I and One-Year CUSTOM II Trial Data for Novel Drug-Eluting Stent System
WASHINGTON, Oct. 22 /PRNewswire-FirstCall/ -- XTENT, Inc. 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 specificity about their questions and the potential impact, if any, on our timeline, we will provide an update."
The company is also reiterating guidance that it expects to commercialize Custom NX in Europe in the second half of 2008.
About the CUSTOM Trials
The CUSTOM I trial is a 30-patient first-in-man study designed to evaluate the preliminary safety and feasibility of in-situ stent customization. CUSTOM I's positive eight-month clinical results have been sustained at two years with no new MACE events, zero restenosis and no late stent thrombosis.
The CUSTOM II trial is a 100-patient study 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 company's CUSTOM III clinical trial completed enrollment in July as previously announced, and the company expects the first available data to be presented at the 2008 Euro-PCR meeting.
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 separation at each 6mm segment and allows for the placement of up to 60mm of stent.
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: XTENT's expectations with respect to the timing of its regulatory filings, the timing of the commercialization of its products and the timing of the initiation of its U.S. pivotal trial. 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, 2007. 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.
Posted: October 2007