Penumbra’s Indigo Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. A minimally-invasive device, Indigo is designed to enable the restoration of blood flow using continuous aspiration for mechanical thrombectomy.
The Indigo Aspiration System is comprised of several devices:
- Indigo Aspiration Catheters
- Indigo Separators
- Indigo Aspiration Tubing
- Indigo Pump/Canister
- Penumbra Aspiration Pump
Our Indigo Aspiration Catheters are designed to deliver continuous high vacuum to remove thrombi and emboli from distal anatomy. Our Indigo Catheters are engineered to be robust, durable and trackable for use in the peripheral anatomy, where clots often form in long segments.
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.
- Simple set-up, portable design
- Pump MAX is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa)
- Indigo Pump/Canister: disposable 1,000 ml collection canister; includes disposable MAX pump/canister tubing
- The Indigo System is an integrated system for use only with other components of the Indigo System including Aspiration Catheters, Separators, Aspiration Tubing, Pump MAX, and MAX Canister