Indigo® System

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System Overview

Penumbra’s Indigo Aspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. The Indigo System utilizes the Penumbra ENGINE® aspiration source capable of delivering nearly pure, continuous vacuum (-29 inHg or 98.2 kPa) to our catheters, enabling thrombus removal in vessels of various sizes.

The Indigo Aspiration System is comprised of several devices:

  • Indigo CAT Mechanical Thrombectomy Catheter
  • Indigo Separator
  • Lightning™ Intelligent Aspiration Tubing
  • Indigo Aspiration Tubing
  • Penumbra ENGINE aspiration source
  • Penumbra ENGINE Canister

The Indigo System is used as a first-line approach or rescue therapy for arterial and venous thrombotic events.

Lightning Intelligent Aspiration

The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Throughout each case, Lightning provides procedural feedback via audiovisual cues. Lightning comes packaged with the Indigo CAT8 or CAT12.  Learn more about Lightning.

Catheters & Separators

The CAT family of catheters is the foundation of Penumbra’s Indigo System. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. Lightning 12 is the next generation of the Indigo System catheters, featuring a large 0.131″ lumen and angled tip for additional circumferential sweep. Made of laser-cut hypotube technology, CAT12 is designed to increase trackability and torqueability. The combination of intelligent aspiration and large-lumen catheter engineering forms Lightning 12: the latest generation in clot removal technology.

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.

As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

Risk Information

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 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.

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Overview

Indigo System | Mechanical Thrombectomy

  • Mechanical clot engagement with proprietary Separator technology
  • Large lumen sustained aspiration
  • Tip directionality for circumferential aspiration
  • Advanced tracking technology with multiple material transitions
  • The Indigo System is an integrated system for use only with other components of the Indigo System including the CAT family of catheters, Separators, Dynamic Aspiration Tubing, Lightning, Penumbra ENGINE, and Penumbra ENGINE Canister

Lightning Intelligent Aspiration

  • Lightning Intelligent Aspiration comes packaged with CAT8 or CAT12
  • Lightning 12: 12 F (4 mm)
    • HTORQ (100, 115 cm lengths)
    • XTORQ (100 cm length)
  • Lightning 8: 8 F (2.67 mm)
    • XTORQ (115 cm length)

CAT Sizes:

  • CAT8: 8 F (2.67 mm)
    • Straight (85 cm)
    • TORQ (85 cm)
    • XTORQ (115 cm)
  • CATD: 8 F (2.67 mm, 50 cm length)
  • CAT6: 6 F (2 mm, 135 cm length)
  • CAT5: 5 F (1.65 mm, 132 cm length)
  • CAT3: 3 F (1.14 mm, 150 cm length)
  • CAT RX: 5.3 F (1.75 mm, 140 cm length)

SEP Sizes:

  • SEP12 (150 cm)
  • SEP8 (150 cm)
  • SEP6 (175 cm)
  • SEP5 (175 cm)
  • SEP3 (190 cm)
  • SEPD (90 cm)
  • SEPC4 (200 cm)

Penumbra ENGINE

  • Sleek, simple design
  • One touch for maximum aspiration
  • Live feedback during the 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 Canister

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