Directional atherectomy with the Omnicath: a unique new catheter system.

Omnicath is a directional atherectomy catheter that employs deflecting nontraumatizing wires to anchor the cutting window at the atherectomy site. This anchoring system regulates the depth of cut and provides directional control and distal perfusion. The system continuously removes debris through a suction port from the operative site. To demonstrate the performance of the device, the Omnicath was tested in the external iliac arteries of ten atherosclerotic Hanford miniature swine in which concentric and eccentric lesions were induced. Five animals were sacrificed 3 days after atherectomy; the remaining five animals were sacrificed 6 weeks after the procedure. The acute histology demonstrates depth of cuts varying from partial plaque removal to near full thickness removal of the arterial wall. Histologic sections of the 6 week follow-up group demonstrated minimal healing response. The anchoring wires did not induce either acute injury or neointimal proliferation in the 6 week follow-up period. In conclusion, the Omnicath permits effective and safe atherectomy in this investigative model.