Penumbra System® JET 7 Reperfusion Catheter
The Penumbra JET® 7 Reperfusion Catheter is intended for use in the revascularization of patients with acute ischemic stroke secondary to large vessel occlusion. The larger lumen of Penumbra JET 7 with XTRA FLEX technology, powered by Penumbra ENGINE®, is designed to increase thrombus removal force. The Penumbra JET 7 with XTRA FLEX allows for the combined use with the 3D Revascularization Device™, which offers four intraluminal chambers designed to lock clot, along with outer petals to trap clot for maximum thrombus extraction.
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.
Indication for Use
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated 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.
Penumbra Aspiration Tubing
As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump
The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
There are no known contraindications.
• The device is intended for single use only. Do not resterilize or reuse. Resterilization and/or Reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target neuro vasculature location.
• Do not use kinked or damaged devices. Do not use open or damaged packages. Return all damaged devices and packaging to the manufacturer/distributor.
• Do not use automated high-pressure contrast injection equipment with the Penumbra Reperfusion Catheter because it may damage the device.
• Do not inject contrast media through the Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology using a syringe or automated high-pressure contrast injection equipment. Injecting contrast media through the Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology may cause the distal tip of the catheter to expand or rupture, resulting in potential vessel damage and subsequent patient injury or death. When injecting contrast media for angiography, always inject through the guide catheter.
• Confirm vessel diameter, and select an appropriate size Penumbra Reperfusion Catheter. Do not use in arteries with diameters smaller or equal to the distal outer diameter of the Penumbra Reperfusion Catheters. Refer to the Reperfusion Catheter labeling for dimensional information.
• Do not advance, retract or use any component of the Penumbra System against resistance without careful assessment of the cause using fluoroscopy. If the cause cannot be determined, withdraw the device or system as a unit. Unrestrained torquing or forced insertion of the catheter, revascularization device, or separator against resistance may result in damage to the device or vessel.
• Do not use the Penumbra System with a pump other than the Penumbra Aspiration Pump.
• The Penumbra System should only be used by physicians who have received appropriate training in interventional neuro-endovascular techniques and treatment of acute ischemic stroke.
• Use prior to the “Use By” date.
• Use the Penumbra System in conjunction with fluoroscopic visualization.
• As in all fluoroscopy procedures, consider all necessary precautions to limit patient radiation exposure by using sufficient shielding, reducing fluoroscopy times and modifying radiation technical factors whenever possible.
• Maintain a constant infusion of appropriate flush solution.
• When performing aspiration, ensure that the Penumbra Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Excessive aspiration or failure to close the Penumbra Aspiration Tubing valve when aspiration is complete is not recommended.
• The Penumbra Separator is not intended for use as a neurovascular guidewire. If repositioning of the Penumbra Reperfusion Catheter is necessary during the revascularization procedure, such reposition should be performed over an appropriate neurovascular guidewire using standard microcatheter and guidewire techniques.
• Administration of anticoagulants and antiplatelets should be suspended until 24 hours post-treatment. Medical management and acute post stroke care should follow the ASA guidelines.1 Any neurological deterioration should be evaluated by urgent CT scan and other evaluations as indicated according to investigator/hospital best practice.
• As in all surgical interventions, monitoring of intra-procedural blood loss is recommended so that appropriate management may be instituted.
• The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology has not been tested for compatibility with other manufacturers’ revascularization devices. The safety and effectiveness of combined use is unknown and could result in damage to the JET 7 Reperfusion Catheter with Xtra Flex technology.
• Use caution and slowly flush heparinized saline. If you see expansion of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology, immediately discontinue use of the catheter.
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, burns, alopecia, or neoplasia from x-ray exposure.
1. Adams, et al., Guidelines for the Early Management of Adults with Ischemic Stroke: A Guideline from the AHA/ASA Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists, Stroke May 2007; 38:1655-1711.
Penumbra JET 7 Reperfusion Catheter
- Large .072″ (1.83 mm) inner lumen designed to increase thrombus removal force
- Designed with XTRA FLEX technology
- Flexible tip design
- Lubricious enhancement
- 20 transitions for trackability and navigation
- 132 cm length
- Progressive distal coil wind enabling superior flexibility
- Enhanced pushability from quad-wire technology
- 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)
- Simple set-up
- Integrated clot catcher
- Disposable Penumbra ENGINE Canister
- Compatible with all Penumbra System Reperfusion Catheters
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