Penumbra JET ™ D Reperfusion Catheter
The Penumbra JET ™ D Reperfusion Catheter is intended for use in the revascularization of patients with acute ischemic stroke secondary to large vessel occlusion. The Penumbra JET D is designed to navigate smaller, distal vessels and extract clot with the power of the Penumbra ENGINE ™ aspiration source.
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.
Penumbra System – Intended Use
As part of the Penumbra System, the Reperfusion Catheters and Separators are intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Aspiration Tubing – Intended Use
As part of the Penumbra System, The Penumbra Sterile Aspiration Tubing is intended to connect the Penumbra Reperfusion 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; intracranial hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; radiation exposure that may lead to cataracts, skin reddening or burns from x-ray exposure.
Penumbra ENGINE – Intended Use
The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems.
Penumbra JET D Reperfusion Catheter
- 1.65 mm outer diameter dedicated for distal occlusions
- Large .054″ / .064″ (1.37 / 1.63 mm) aspiration lumen
- 138 cm to reach distal anatomy
- Part of the Penumbra System™, intended for use with Hi-Flow Aspiration Tubing, Penumbra ENGINE, and Penumbra ENGINE Canister
Penumbra ENGINE Aspiration Source
- Capable of delivering and maintaining nearly pure vacuum (-29.2 inHg or 98.9 kPa) 1
- Simple set-up
- Integrated clot catcher
- Disposable Penumbra ENGINE Canister
- Compatible with all Penumbra System Reperfusion Catheters