ROTAPRO™ROTAPRO™ 2.0 Pre-Connected Burr and Advancing Device - 1.25mm

Percutaneous rotational coronary atherectomy with the ROTAPRO Rotational Atherectomy System, as a sole therapy or with adjunctive percutaneous 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.