Aspiration Catheters
Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System)
Indications for Use
INDIGO Aspiration Catheters and Separators: As part of the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System), the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. Not for use in the coronaries or the neurovasculature. INDIGO Aspiration Tubing: As part of the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System), the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Pump MAX. Penumbra Pump MAX: The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.
Key Specifications
- Aspiration Catheter Materials: Biocompatible, commonly utilized for interventional devices
- Coating: Hydrophilic
- Markerband: Radiopaque
- Guidewire compatible: Yes
- Aspiration Catheter OD (Maximum): 0.051” – 0.080” [1.295mm – 2.030mm]
- Aspiration Catheter Working Length: 125cm – 153cm
- Separator Distal OD: 0.022” – 0.045” [0.56mm – 1.14mm]
- Separator Working Length: 135cm – 155cm
- Aspiration Tubing ID: 0.071” – 0.110” [1.8mm – 2.8mm]
- Aspiration Tubing Length: 112.0” [284.5cm]
- Sterilization: EO (Ethylene Oxide)
- Shelf-Life: 36 Months
- Penumbra Pump MAX Vacuum: Up to 29 inHg
- Penumbra Pump MAX Voltage: 100-115 Vac / 230 Vac
- Penumbra Pump MAX Frequency: 50 Hz / 60 Hz
- IEC 60601-1 Compliance: Yes
- IEC 60601-1-2 Compliance: Yes
- Devices provided sterile, non-pyrogenic, single use only
- Available in multiple configurations
- Pre-packaged KIT configuration for Aspiration Catheters with Aspiration Tubing
- Visible under fluoroscopy
- Penumbra Pump MAX is portable and operates on AC power
- INDIGO Separator used to clear catheter lumen if blocked
- No separator needed for catheters with I.D. of 0.054in [1.37mm] or larger
Description
The Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) is intended for the removal of fresh, soft emboli and thrombi from vessels of the arterial and venous systems. The Aspiration Catheter and Separator are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only. Additionally, a pre-packaged configuration (KIT packaging) for the Aspiration Catheters with Aspiration Tubing is available. The INDIGO Aspiration System is designed to remove thrombus from the vasculature using continuous aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The Penumbra Pump MAX is the aspiration source, providing vacuum of up to 29 inHg, and is portable if needed.