RotaLink Exchangeable Catheter - Catheter, angioplasty, atherectomy

Intended purpose

The RotaLink Catheter is intended to be connected to a Rotablator Advancer and 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

The RotaLink catheter consists of a drive shaft, a sheath, and an integral burr and is intended to be connected to the Rotablator Advancer. Once connected, the advancer (via means of an air turbine) causes the burr to rotate. The drive shaft has a central lumen for a guide wire to pass through and is covered by a sheath, which protects arterial tissue from the spinning drive shaft and permits the passage of saline to lubricate and cool the drive shaft.