RotaLink Plus - Catheter, angioplasty, atherectomy

Intended purpose

The RotaLink Plus device, consisting of a Rotablator Advancer preconnected to a RotaLink Catheter, is intended to perform percutaneous rotational coronary angioplasty as a sole therapy or with adjunctive balloon angioplasty in patients with coronary artery disease who are acceptable candidates for coronary artery bypass graft surgery and who meet one of the following criteria: - Single vessel atherosclerotic coronary artery disease with a stenosis that can be passed with a guidewire - Multiple vessel coronary artery disease that in the physicians judgement does not pose undue risk to the patient - Certain patients who have had prior percutaneous transluminal coronary angioplasty (PTCA) and who have restenosis of the native vessel - Native vessel atherosclerotic coronary artery disease that is less than 25mm in length

Functional description

RotaLink Plus consists of a Rotablator Advancer preconnected to a RotaLink Exchangeable Catheter. The advancer houses the air turbine which powers the burr and functions as a guide for the sliding elements that control burr advancement. The catheter portion of the device, which includes the integral burr, is tracked over a guidewire through the vasculature to the treatment site. The burr then ablates plaque into fine particles that are disposed of by the body?s reticuloendothelial system.