Penumbra System MAX Family of Reperfusion Catheters
The Penumbra System MAX family of Reperfusion Catheters are intended for use in the revascularization of patients with acute ischemic stroke secondary to large vessel occlusion disease.
The 3MAX and 4MAX Reperfusion Catheters feature MAX tracking technology and are designed to be delivered over a guidewire to distal occlusions. The 5MAX combines MAX tracking technology with a larger lumen, and is delivered using a coaxial technique.
The MAX family of Reperfusion Catheters are intended for use with Pump MAX and Hi-Flow Aspiration Tubing.
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.
Penumbra Pump MAX – Intended Use
The Penumbra Pump MAX is intended as a vacuum source for the Penumbra Aspiration Systems.
3MAX Reperfusion Catheter
- 4.7 F (1.57 mm) proximal / 1.27 mm distal outer diameter
- .035″ (.89 mm) distal / .043″ (1.09 mm) proximal inner diameter
4MAX Reperfusion Catheter
- 6 F (2.03 mm) proximal / 1.42 mm distal outer diameter
- .041″ (1.04 mm) distal / .064″ (1.63 mm) proximal inner diameter
5MAX Reperfusion Catheter
- 6 F (2.03 mm) proximal / 1.67 mm distal outer diameter
- .054″ (1.37 mm) distal / .064″ (1.63 mm) proximal inner diameter