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, and certain central circulatory system conditions such as pulmonary emboli. 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 and Separators
- Indigo Aspiration Tubing
- Penumbra ENGINE Canister
- Penumbra ENGINE aspiration source
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 can form in long segments.
Penumbra ENGINE facilitates an easy, simple set-up and the integrated clot catcher allows for immediate live feedback of thrombus removal during cases.
The Penumbra Indigo System Separator is intended for use with our Indigo System’s CAT family of catheters to enable the removal of a wide range of thrombus.
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 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 and certain central circulatory system conditions such as pulmonary emboli using continuous aspiration.
Aspiration Tubing – Intended Use
The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump.
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 ENGINE – Intended Use
The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems.
- Simple set-up, portable design
- Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposable Penumbra ENGINE Canister1
- The Indigo System is an integrated system for use only with other components of the Indigo System including Aspiration Catheters, Separators, Aspiration Tubing, Penumbra ENGINE, and Penumbra ENGINE Canister