Sixteen patients with a mean age of 65.4 +/- 9.8 years and suffering from peripheral vascular disease underwent peripheral atherectomy using a new mechanical device--the BARD Rotary Atherectomy System (BRAS). The BRAS is an "over the wire" system that consists of a spiral guidewire and a handheld motor drive unit, which rotates at 1,500 rpm. Prior to the procedure angiography demonstrated the presence of 18 obstructions (1 tibial, 2 popliteal, 15 superficial femoral arteries) with a mean stenosis of 95.7 +/- 8%. Successful atherectomy was achieved in 16 of 18 lesions and resulted in an 89% immediate success rate and a significant (P less than 0.01) reduction of stenosis to 37.8 +/- 12.5%. There were no significant complications. The excised and removed material embedded over the spiral guidewire demonstrated the presence of fibrotic tissue, fatty lesions, and calcium deposits. Medial or adventitial layers were not present in the removed atherosclerotic material. Mean ABI was significantly (P less than 0.01) increased from 0.38 +/- 0.17 to 0.55 +/- 0.21 following atherectomy. Angiographic follow-up obtained in ten patients 8.8 +/- 5.2 months following the procedure demonstrated restenosis in six of those ten patients. The ABI at this time remained unchanged. These results demonstrated that the new BRAS mechanical atherectomy system is feasible and safe for recanalization of severely stenosed arteries in patients with peripheral vascular disease.