Indigo Aspiration Catheters (CAT) are the foundation of Penumbra’s Indigo System. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Available in a selection of sizes, the CAT family can enable access to distal peripheral vessels of the upper and lower extremities, including below the knee.
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.
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 is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems, and certain central circulatory systems conditions such as pulmonary emboli, using continuous aspiration.
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.
- Mechanical clot engagement
- Large lumen aspiration
- Tip directionality for circumferential aspiration
- Proprietary tracking technology
- Multiple material transitions
- CAT8—8.0 F (2.67 mm)
- Straight, 85 cm length
- TORQ, 85 cm length
- XTORQ, 115 cm length
- CATD—8.0 F (2.67 mm, 50 cm length)
- CAT6—6.0 F (2 mm, 135 cm length)
- CAT5—5.0 F (1.65 mm, 132 cm length)
- CAT3—3.4 F (1.14 mm, 150 cm length)
- SEP8 (150 cm)
- SEP6 (175 cm)
- SEP5 (175 cm)
- SEP3 (190 cm)
- SEPD (90 cm)
- Simple design
- One touch for maximum aspiration
- Live feedback during procedure with integrated clot catcher
- Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposable Penumbra ENGINE Canister1