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
The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease using continuous aspiration.
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.
- Specialised architecture designed to minimise vessel wall contact
- Four intraluminal chambers engineered to lock, and petals to trap, for clot extraction in combination with Penumbra JET 7 and ACE Reperfusion Catheters
- Provides up to five retrieval passes into Penumbra JET 7 and ACE Reperfusion Catheters
- Four distal markers along the length of 3D™ to support device placement
- Designed for delivery with the Velocity™ Delivery Microcatheter