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Penumbra, Inc. (Peripheral Vascular)
1351 Harbor Bay Parkway, Alameda, CA 94502
PHONE: (510) 748-3200 | FAX: (510) 748-3232
Embolization / Embolization Coils
View Chart| Company Name | Product Name | Type (Detachable, Pushable) | Material | Coil Diameter (mm) | Coil Length (cm) | Recommended Delivery Catheter Sizes (ID) (inch) | US FDA Indicated Use |
|---|---|---|---|---|---|---|---|
| Penumbra, Inc. (Peripheral Vascular) | Packing Coil | Detachable | Platinum | Wave shape designed to conform to vessel diameter | 5, 15, 30, 45, 60 | 0.025–0.027 high-flow microcatheters (Lantern) | Indicated for the embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, and arterial and venous embolizations in the peripheral vasculature |
| Penumbra, Inc. (Peripheral Vascular) | Packing Coil LP | Detachable | Platinum | Wave shape conforms to vessel diameter | 3, 6, 10, 15, 30, 45, 60 | 0.0165–0.021 (low-profile microcatheter) | Indicated for the endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and arterial and venous embolizations in the peripheral vasculature |
| Penumbra, Inc. (Peripheral Vascular) | POD | Detachable with dedicated anchor segment for high flow vessel sacrifice | Platinum | 3, 4, 5, 6, 8, 10, 12, 14 | 20–60 | 0.025–0.027 high-flow microcatheters (Lantern) | For coils with nominal sizes ≤ 6 mm: indicated for the embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, arterial and venous embolizations in the peripheral vasculature; for coils with nominal sizes > 6 mm: indicated for arterial and venous embolizations in the peripheral vasculature |
| Penumbra, Inc. (Peripheral Vascular) | Ruby Coil | Detachable | Platinum | 2–40 (3D complex shape, multiple softness levels) | 1–60 | 0.025–0.027 high-flow microcatheters (Lantern) | Arterial and venous vessel embolization in the peripheral vasculature |
| Penumbra, Inc. (Peripheral Vascular) | Ruby Coil LP | Detachable | Platinum | 1–10 (3D complex shape) | 1–70 | 0.0165–0.021 (low-profile microcatheter) | Indicated for the endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and arterial and venous embolizations in the peripheral vasculature |
| Penumbra, Inc. (Peripheral Vascular) | Packing Coil XL | Detachable | Platinum | Wave shape designed to conform to vessel diameter | 15, 30,45, 55, 70 | Catheter compatible with 0.035 (0.89 mm) or larger guidewires | The Ruby XL System is indicated for arterial and venous embolizations in the peripheral vasculature |
| Penumbra, Inc. (Peripheral Vascular) | POD XL | Detachable | Platinum | Designed to anchor for high-flow vessels (4–16) | 10, 20,30, 55, 70 | Catheter compatible with 0.035 (0.89 mm) or larger guidewires | The Ruby XL system is indicated for arterial and venous embolizations in the peripheral vasculature |
| Penumbra, Inc. (Peripheral Vascular) | Ruby Coil XL | Detachable | Platinum | Designed to frame in large aneurysms (20–40) | 55, 70 | Catheter compatible with 0.035 (0.89 mm) or larger guidewires | The Ruby XL system is indicated for arterial and venous embolizations in the peripheral vasculature |
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Sheaths / Special Access Sheaths
View Chart| Company Name | Product Name | Size (F) | Length (cm) | Guidewire Compatibility (inch) | Curved or Straight | Radiopaque Tip | Type of Special Access |
|---|---|---|---|---|---|---|---|
| Penumbra, Inc. (Peripheral Vascular) | Element Vascular Access System | 17 | 13, 33, 45, 65 | 0.038 | Straight | Yes | Designed to provide a conduit for introduction of therapeutic or diagnostic devices into the vasculature |
Sheaths / Standard Sheaths
View Chart| Company Name | Product Name | Size (F) | Length (cm) | Guidewire Compatibility (inch) | Curved or Straight | Radiopaque Tip |
|---|---|---|---|---|---|---|
| Penumbra, Inc. (Peripheral Vascular) | Element Vascular Access System | 17 | 13, 33, 45, 65 | 0.038 | Straight | Yes |
Other Devices / Mechanical Thrombectomy/Thrombolysis (Peripheral/Venous)
View Chart| Company Name | Product Name | Sheath Compatibility (F) | Guidewire Compatibility (inch) | Working Length (cm) | Mode of Operation | US FDA Indicated Use |
|---|---|---|---|---|---|---|
| Penumbra, Inc. (Peripheral Vascular) | Indigo System Separator SEPC4 | – | – | 200 | Separator-assisted clot debulking, if needed | 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 |
| Penumbra, Inc. (Peripheral Vascular) | Indigo System Catheter CAT RX | 6 (guide catheter) | 0.014 | 140 | The Indigo System CAT RX is paired with the Penumbra ENGINE to provide sustained, powerful aspiration | 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 |
| Penumbra, Inc. (Peripheral Vascular) | Indigo System Catheters: Lightning Bolt 6X with TraX | 6 | 0.014 | 132, 150 | The Lightning Bolt Aspiration Tubing (Indigo Aspiration Tubing) is designed to serve as a conduit to assist in thrombus removal, facilitating transfer of vacuum between the Penumbra Aspiration Pump and the Indigo Aspiration Catheter while providing intermittent, continuous, or modulated aspiration; modulated aspiration is provided when the Lightning Bolt Aspiration Tubing alternates between connecting the Indigo Aspiration Catheter to the Penumbra Aspiration Pump and a sterile saline intravenous bag at ambient pressure | 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 and for the treatment of pulmonary embolism. As part of the Indigo Aspiration System, the Indigo Sterile Aspiration Tubing is indicated to connect the Indigo Aspiration Catheters to the Penumbra Aspiration Pump |
| Penumbra, Inc. (Peripheral Vascular) | Indigo System Catheters: Lightning Bolt 12 | 12 | 0.014–0.038 | 100–115 | The Lightning Bolt Aspiration Tubing (Indigo Aspiration Tubing) is designed to serve as a conduit to assist in thrombus removal, facilitating transfer of vacuum between the Penumbra Aspiration Pump and the Indigo Aspiration Catheter while providing intermittent, continuous, or modulated aspiration; modulated aspiration is provided when the Lightning Bolt Aspiration Tubing alternates between connecting the Indigo Aspiration Catheter to the Penumbra Aspiration Pump and a sterile saline intravenous bag at ambient pressure | 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 and for the treatment of pulmonary embolism; as part of the Indigo Aspiration System, the Indigo Sterile Aspiration Tubing is indicated to connect the Indigo Aspiration Catheters to the Penumbra Aspiration Pump |
| Penumbra, Inc. (Peripheral Vascular) | Indigo System Separators: SEP12, SEP7, SEP7D, SEP6, SEP5, SEPC4 | – | – | 90–200 | The device is advanced and retracted through the Indigo catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the catheter tip, as needed | 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 and for the treatment of pulmonary embolism; 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 |
| Penumbra, Inc. (Peripheral Vascular) | Indigo System Catheters: Lightning Flash 2.0 with Select + | 16 | 0.014–0.038 | 80–115 | Lightning Flash Aspiration Tubing facilitates the transfer of vacuum between CAT16 Aspiration Catheter and Penumbra Aspiration Pump while providing intermittent or continuous aspiration. Intended users for this device are physicians who have received appropriate training in interventional techniques .The Indigo Lightning Flash Aspiration System is kitted with the Select + Catheter. The Select + Catheter is used to aide in tracking the aspiration catheter to the site of occlusion and is removed prior to initiating aspiration with the aspiration catheter | Indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems and for the treatment of pulmonary embolism; as part of the Indigo Aspiration System, the Indigo Sterile Aspiration Tubing is indicated to connect the Indigo Aspiration Catheters to the Penumbra Aspiration Pump |
| Penumbra, Inc. (Peripheral Vascular) | Indigo System Catheters: Lightning Bolt 7 | 7 | 0.014–0.038 | 130 | The Lightning Bolt Aspiration Tubing (Indigo Aspiration Tubing) is designed to serve as a conduit to assist in thrombus removal, facilitating transfer of vacuum between the Penumbra Aspiration Pump and the Indigo Aspiration Catheter while providing intermittent, continuous, or modulated aspiration; modulated aspiration is provided when the Lightning Bolt Aspiration Tubing alternates between connecting the Indigo Aspiration Catheter to the Penumbra Aspiration Pump and a sterile saline intravenous (IV) bag at ambient pressure | 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 and for the treatment of pulmonary embolism; as part of the Indigo Aspiration System, the Indigo Sterile Aspiration Tubing is indicated to connect the Indigo Aspiration Catheters to the Penumbra Aspiration Pump |
| Penumbra, Inc. (Peripheral Vascular) | Indigo System Catheters: CAT7D, CAT6, and CAT RX | 7 (CAT7D); 6 (CAT6); 6F guide catheter (CAT RX) | 0.014–0.038 | 50–150 | The Indigo System Catheters are paired with the Penumbra ENGINE for continuous, powerful aspiration | 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 and for the treatment of pulmonary embolism; as part of the Indigo aspiration system, the Indigo Sterile aspiration tubing is indicated to connect the Indigo aspiration catheters to the Penumbra aspiration pump; 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 |
Other Devices / Occlusion Devices
View Chart| Company Name | Product Name | Type | Position | US FDA Indicated Use |
|---|---|---|---|---|
| Penumbra, Inc. (Peripheral Vascular) | Packing Coil | Detachable | High-flow microcatheter deliverable | Indicated for the embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, and arterial and venous embolizations in the peripheral vasculature |
| Penumbra, Inc. (Peripheral Vascular) | Packing Coil LP | Detachable | Low-profile microcatheter deliverable | The Penumbra LP Coil System is indicated for the embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and arterial and venous embolizations in the peripheral vasculature |
| Penumbra, Inc. (Peripheral Vascular) | POD | Detachable with dedicated anchor segment designed for high flow vessel sacrifice | High-flow microcatheter deliverable | For POD Coils with nominal sizes ≤ 6 mm: indicated for the embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, arterial and venous embolizations in the peripheral vasculature; for POD Coils with nominal sizes > 6 mm: indicated for arterial and venous embolizations in the peripheral vasculature |
| Penumbra, Inc. (Peripheral Vascular) | Ruby Coil LP | Detachable | Low-profile microcatheter deliverable | The Penumbra LP Coil System is indicated for the embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and arterial and venous embolizations in the peripheral vasculature |
Catheters / Microcatheters
View Chart| Company Name | Product Name | Type of Catheter Construction | Proximal Size (F) | Middle Size (F) | Distal Size (F) | Catheter Working Length (cm) | Catheter Endhole Diameter ID (inch) | Recommended Guidewire Size (inch) | Radiopaque Tip (Yes/No) | Hydrophilic Coating (Yes/No) |
|---|---|---|---|---|---|---|---|---|---|---|
| Penumbra, Inc. (Peripheral Vascular) | Lantern Delivery Microcatheter | Nitinol coil reinforced; eight extrusion zones; three tip shapes: straight, 45°, and 90° | 2.95 | – | 2.6 | 115, 135, 150 | 0.025 | 0.014/0.018 | Yes, two markerbands, radiopaque 3 cm | Yes |
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