FDAnews Device Daily Bulletin


Nov. 29, 2005

CABG Medical has suspended enrollment in its international clinical trial of the Holly Graft System (HGS) after two of the grafts were determined to have closed prior to the patient's discharge from the hospital.

A total of eight patients have been treated with an anticoagulant regimen of aspirin and warfarin, the firm said. The decision follows CABG Medical's recent announcement that the first enrollment arm -- consisting of 36 patients implanted with the HGS and treated with an anti-platelet regimen of aspirin and clopidogrel -- failed to meet standards necessary to obtain regulatory approval.

"The incorporation of warfarin into the treatment regimen of HGS patients has not prevented occlusions in the limited set of patients treated with this regimen," said Manny Villafana, chairman and CEO of CABG Medical. "The results are disappointing and at this time do not warrant further evaluation in clinical trials."

Villafana noted the majority of the failures apparently were due to graft occlusions rather than restenosis, and the firm will aggressively seek the cause of these failures. "We are in the process of reviewing all of our clinical and preclinical data to determine whether any modifications can be made to the HGS which would reduce the occurrence of occlusion to a level necessary to meet standards required to obtain regulatory approvals," Villafana said. "Such modifications may take up to twelve to eighteen months to implement and test preclinically."