The Penumbra Indigo System Separators are designed for use with the Indigo Aspiration Catheters. The Indigo Separator is advanced and retracted through the corresponding size Indigo Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the catheter tip.
The Indigo System with the Separator enables a wide range of clot morphology to be removed from the body.
Caution: Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use.
Indigo Aspiration System – Intended Use
The Indigo Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems using continuous aspiration.
Potential Adverse Events
Possible complications include, but are not limited to, the following:
allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or
perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; respiratory failure; peripheral thromboembolic events.
Penumbra Pump MAX – Intended Use
The Penumbra Pump MAX is intended as a vacuum source for the Penumbra Aspiration Systems.
- SEP8 (150 cm length)
- SEP6 (175 cm length)
- SEP5 (175 cm length)
- SEP3 (190 cm length)
- SEPD (90 cm length)