ROTAPRO Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device - Catheter, angioplasty, atherectomy

Intended purpose

Percutaneous rotational coronary atherectomy system, as a sole therapy or with adjunctive perctatneous coronary intervention (PCI)is indicated in patients with calcific coronary artery disease who meet one of the following selection 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 physician’s judgment does not pose undue risk to the patient; • Patients who have had prior PCI, and who have native coronary artery post-balloon angioplasty restenosis; or, • Native vessel atherosclerotic coronary artery disease that is less than 25 mm in length

Functional description

The ROTAPRO Rotational Atherectomy System has four main components, guidewire, advancer, catheter, and console system, which includes the console and compressed gas supply. The advancer acts as a support for the gas turbine and as a guide for the sliding elements which control burr extension. ROTAPRO Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device consists of ROTAPRO Advancer pre-connected with burr catheter for physician convenience and procedural flexibility.