Peripheral ROTAPRO™ Rotational Atherectomy System
Indications, Safety, and Warnings
INTENDED USE/INDICATIONS FOR USE
The Peripheral ROTAPRO is intended for percutaneous use in the peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for endovascular procedures.
- Occlusions through which a guidewire will not pass.
- Use in coronary arteries.
- Long (≥ 20 cm) total occlusions.
- Angiographic evidence of thrombus prior to treatment with the Peripheral ROTAPRO. Such patients may be treated with thrombolytics (e.g., Urokinase).
- Angiographic evidence of significant vessel trauma at the treatment site.
The use of Peripheral ROTAPRO for in-stent restenosis might lead to damage of stent components and/or the Peripheral ROTAPRO, which may lead to patient injury. Percutaneous rotational atherectomy with the Peripheral ROTAPRO should only be carried out at medical facilities where prompt treatment can be immediately performed in the event of a potentially injurious or serious complication.
Potential adverse reactions which may result from the use of this device include but are not limited to:
- Allergic reaction (to drug, contrast, device or other)
- Cerebrovascular accident (CVA)/ Stroke/Transient ischemic attack (TIA)
- Electric shock
- Embolism (e.g. air, plaque, thrombus, device, tissue, or other)
- Hypotension/ hypertension
- Need for additional intervention or surgery, including amputation
- Thrombus/ thrombosis
- Vessel occlusion
- Vessel trauma (e.g. dissection, AV fistula, perforation, pseudoaneurysm, rupture)