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At one-year CUSTOM II clinical follow-up and at two-year CUSTOM I clinicalfollow-up, no new major adverse cardiac events (MACE) were reported. Theincidence of late stent thrombosis for patients treated with Custom NX in bothtrials was zero percent.
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"These long term results are exceptional. CUSTOM I and II are unlike anyother early stage drug-eluting stent trial because of the lesion length andcomplexity of the patients treated in these trials," said Professor EberhardGrube, M.D., chief of cardiology at the HELIOS Heart Center in Siegburg,Germany, and Principal Investigator of CUSTOM I and CUSTOM II. ProfessorGrube presented CUSTOM I two-year results and CUSTOM II one-year resultsduring a satellite symposium Sunday evening at the Cardiovascular ResearchFoundation's (CRF) nineteenth annual Transcatheter Cardiovascular Therapeutics(TCT) meeting.
Additionally, the company announced it recently filed its InvestigationalDevice Exemption (IDE) to begin the CUSTOM IV pivotal trial and has nowreceived questions back from the Food and Drug Administration (FDA)."Submission of our IDE was a significant milestone for the company and allowsus to have clear discussions with the agency about the requirements necessaryto gain approval to start the trial and continue our progress to bring CustomNX to physicians and patients," said Gregory D. Casciaro, President and CEO ofXTENT. "We are quickly mobilizing to work with the FDA and as soon as we havespecificity about their questions and the potential impact, if any, on ourtimeline, we will provide an update."
The company is also reiterating guidance that it expects to commercializeCustom 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 evaluatethe preliminary safety and feasibility of in-situ stent customization. CUSTOMI's positive eight-month clinical results have been sustained at two yearswith no new MACE events, zero restenosis and no late stent thrombosis.
The CUSTOM II trial is a 100-patient study designed to evaluate the safetyand efficacy of Custom NX for the treatment of long and multiple lesions. Ofthe 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 IIenrolled one of the most difficult to treat patient populations ever studiedin a DES trial. In the CUSTOM II patient population, the average vesseldiameter was 2.57mm and the average lesion length was 28.7mm. Twenty-sixpercent of the study participants were diabetic. The percentage of patientswith ACC/AHA lesion grade B2 or C was 65.1 percent. CUSTOM II's six-monthclinical results have been sustained at one year. The target lesionrevascularization rate remained constant at four percent, with no new MACEevents, and no late stent thrombosis.
The company's CUSTOM III clinical trial completed enrollment in July aspreviously announced, and the company expects the first available data to bepresented at the 2008 Euro-PCR meeting.
About the Custom NX(R) DES System
Custom NX is designed to enable a more personalized approach to thetreatment of arterial disease based on each patient's individual lesioncharacteristics. The Custom NX system allows physicians to customize thelength and diameter of the stent at the site of the lesion. The systemfeatures a proprietary modular stent design that consists of multiple 6mmcobalt chromium segments coated with Biolimus A9(R) and PLA, a biodegradabledrug carrier. The Custom NX delivery system enables sep
