DIRECTIONAL ATHERECTOMY WITH THE OMNICATH(TM) - A UNIQUE NEW CATHETERSYSTEM

Omnicath(TM) is a directional atherectomy catheter that employs deflec ting nontraumatizing wires to anchor the cutting window at the atherec tomy site. This anchoring system regulates the depth of cut and provid es directional control and distal perfusion. The system continuously r emoves debris through a suction port from the operative site. To demon strate the performance of the device, the Omnicath(TM) was tested in t he external iliac arteries of ten atherosclerotic Hanford miniature sw ine in which concentric and eccentric lesions were induced. Five anima ls were sacrificed 3 days after atherectomy; the remaining five animal s were sacrificed 6 weeks after the procedure. The acute histology dem onstrates depth of cuts varying from partial plaque removal to near fu ll thickness removal of the arterial wall. Histologic sections of the 6 week follow-up group demonstrated minimal healing response. The anch oring wires did not induce either acute injury or neointimal prolifera tion in the 6 week follow-up period. In conclusion, the Omnicath(TM) p ermits effective and safe atherectomy in this investigative model. (C) 1994 Wiley-Liss, Inc.