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March 7 – March 13

March 8th: X-Cell Medical Initiates Enrollment for ETHOS II Clinical Trial of Estradiol Eluting Stent

X-Cell Medical, Inc. announced today that the Company has initiated enrollment in its multinational clinical trial to study the safety and effectiveness of the ETHOS (Estradiol eluting stents in Humans for restenosis) II Coronary Stent System.

ETHOS II drug eluting stents (DES) are coated with a second generation formulation of 17(beta)-estradiol, an approved drug used in hormone replacement therapy and other indications. The ETHOS II trial is complimentary to the Company's ongoing ETHOS I trial, with full 6-month follow-up data to be reported in 2H 2006. ETHOS II is been designed as part of our company commitment to create a DES system with superior safety characteristics.

ETHOS II is a three-center, open label study during which patients will receive a novel formulation of estradiol with reduced polymer load. The study will include 35 patients with diagnosed stable and unstable angina or documented silent ischemia, with angiographic and intravascular ultrasound (IVUS) follow-up at 6 months to measure the percent in-stent volume obstruction. The data from ETHOS II will be compared with ETHOS I, which also includes a leading bare-metal stent, for the elimination of restenosis in patients eligible for balloon angioplasty with symptomatic ischemic heart disease due to discrete de novo and/or restenotic coronary artery lesions. Ultimately, the results of this comparison will enable X-Cell to proceed toward a US pivotal trial with a fully optimized product.

March 12th: Two studies of Drug Coated Stents with different brands produce similar results

If a bare-metal stent fails to keep an artery open, implanting a second, drug-coated stent is better than using radiation therapy, the only approved standard treatment, two new studies show. Johnson & Johnson, whose stents are coated with sirolimus; and Boston Scientific, whose stents are coated with paclitaxel, the results could set the stage for a major head-to-head trial of the two contenders.

The original stents were all bare metal, but coated stents have become predominant since their introduction in the United States two years ago.

Even when a stent is in place, an artery can become blocked again. That happens about 20 percent of the time with bare-metal stents, and much less frequently with coated stents.

Each of the two studies compared a coated stent with vascular brachytherapy, which is radiation therapy and currently the only treatment approved by the U.S. Food and Drug Administration for what is formally called restenosis after a bare-metal stent has been implanted.

The results were strikingly positive for sirolimus in terms of the primary endpoint. Trial included 384 patients whose arteries began to close again after implant of a bare-metal stent. Only 10 percent of the 259 patients who got drug-coated stents suffered a major adverse cardiac event over the next nine months, compared to 19.2 percent of the 125 patients who got radiation therapy. There was also a significant difference in the rate of failure of the treated artery 21.6 percent in the radiation group, 12.4 percent in the sirolimus stent group.

In paclitaxel trial, the rate of major adverse cardiac events among the 396 patients in the nine months following treatment was 43 percent lower for those who got coated stents than for those who got radiation therapy. These are two different studies done in different fashions, but the extent of benefit provided by each one over radiation seems to be similar. Coated stents may become the treatment of choice following failure of bare-metal stents. Aside from their increased effectiveness, the stents also are easier to administer than radiation therapy

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