FDAnews Device Daily Bulletin


Nov. 17, 2005

The initial results of a clinical trial of CABG Medical's drug-eluting graft do not meet standards necessary for FDA approval and distribution, the firm said.

CABG recently completed the first arm of its international clinical trial of the Holly Graft System (HGS), a drug eluting graft (DEG) used in a coronary artery bypass procedure. This phase consisted of 35 patients implanted with the HGS and treated with an anti-platelet regimen of aspirin and Plavix (clopidogrel).

Twelve grafts have been determined to be occluded and nonfunctional, the firm said. In addition, two patients experienced adverse events -- including one death that was determined not to be related to device performance -- and one adverse event in which the HGS was removed from the patient prior to the completion of the surgery.

The majority of the remaining 21 patients have been examined prior to discharge and, to the company's knowledge, are in good health, CABG said. The company added it does not know if these grafts continue to be functional. None of these patients have undergone a long-term follow-up examination and the ultimate efficacy of the device cannot be assessed until such data is collected, CABG said.

The company's next trial will consist of five patients. Clinicians will treat these patients with an anticoagulant regimen of aspirin and warfarin rather than aspirin and clopidogrel, and will follow these patients for 60 days to evaluate the efficacy of the aspirin and warfarin regimen. If the initial results from these patients is positive, this arm will be expanded to include a total of approximately 30 patients, CABG said.

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