Innovation: Penumbra JET™ Family & Penumbra ENGINE™

Latest Advancements in Stroke Thrombectomy Aspiration Technology Featured at Key Meetings

 

At the recent AANS/CNS Joint Cerebrovascular Annual Meeting and International Stroke Meeting, both held in Honolulu, HI (USA), Penumbra featured the latest advancements with the Penumbra System® for ischemic stroke: Penumbra JET 7 and Penumbra JET D Reperfusion Catheters powered by Penumbra ENGINE aspiration source. All are part of the fully integrated Penumbra System that utilizes aspiration-based mechanical thrombectomy for stroke revascularization.

The Penumbra JET 7 and JET D Reperfusion Catheters deliver deep vacuum aspiration power of the Penumbra ENGINE to enable physicians to extract thrombus effectively and safely in acute ischemic stroke patients. “Penumbra is delighted to usher in our next phase of innovation with the introduction of the Penumbra JET 7, JET D, and ENGINE,” said Adam Elsesser, chairman and chief executive officer of Penumbra. “Each phase of innovation —original Penumbra System, MAX™ and ACE™ systems, and now JET and ENGINE — represents a significant improvement in performance and the opportunity to further help patients experiencing acute ischemic stroke.”

Innovation: Penumbra JET™ Family & Penumbra ENGINE™

The Penumbra JET 7 is the Penumbra System’s seventh generation Reperfusion Catheter for proximal large vessel occlusions, and Penumbra JET D Reperfusion Catheter is designed specifically for distal occlusions. Penumbra JET 7 Reperfusion Catheter has a large 0.072″ lumen for deep vacuum aspiration and is designed for trackability and navigation, featuring 20 transitions from the proximal shaft to distal tip, a progressive distal coil wind for superior flexibility and Quad-Wire technology in the proximal shaft for enhanced pushability. JET D brings deep vacuum aspiration power to distal occlusions with a smaller profile.

Innovation: Penumbra JET™ Family & Penumbra ENGINE™

Both JET 7 and JET D are supported by Penumbra’s third generation aspiration source, Penumbra ENGINE, which offers the deepest vacuum available with the Penumbra System. Penumbra ENGINE offers near perfect vacuum (-29.2 in Hg) and features a new sleek simple design with one-touch aspiration control, a new canister with integrated clot catcher and LED canister lighting. Together, the Penumbra System with the new Penumbra JET 7 Reperfusion Catheter powered by the Penumbra ENGINE offers the highest thrombus removal force for revascularization of acute ischemic stroke patients with large vessel occlusions.

Innovation: Penumbra JET™ Family & Penumbra ENGINE™

For more information, please link to our new product webpage — Penumbra System® JET Family of Reperfusion Catheters  — and/or related press release.

Risk Information

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 3D Revascularization Device
As part of the  Penumbra System, the Penumbra 3D Revascularization Device is 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) 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.
Contraindications
There are no known contraindications.
Warnings
• 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.
• 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 3D Revascularization Device has not been evaluated in patients with angiographic evidence of pre-existing arterial injury.
• The use of fluoroscopy may present potential risks from radiation exposure. The probability of adverse events due to radiation exposure increases with the total amount of radiation observed, the number of procedures and total procedure time.
Precautions
• 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.
• 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 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 repositioning should be performed over an appropriate neurovascular guidewire using standard microcatheter and guidewire techniques.
• Do not use automated high-pressure contrast injection equipment with the Penumbra Reperfusion Catheter because it may damage the device.
• Administration of anticoagulants and antiplatelets should be suspended until 24 hours post-treatment. Medical management and acute post stroke care should follow the ASA guidelinesi. 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.
• Confirm vessel diameter, and select an appropriate size Penumbra Reperfusion Catheter. Limit the usage of Reperfusion Catheters to arteries larger than the catheter’s outer diameter. Refer to the Reperfusion Catheters to arteries larger than the catheter’s outer diameter. Refer to the Reperfusion Catheter labeling for dimensional information.
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
i 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 Artherosclerotic 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 ENGINE – Indication For Use
The Penumbra ENGINE is indicated as a vacuum source for the Penumbra Aspiration Systems.
Contraindications
There are no contraindications.
Warnings/Precautions
• The canister is intended for single use only. Do not reuse. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate.
• Do not block bottom or back air vents. Unit may overheat and shut off or fail to restart if run for extended periods without airflow.
• To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth.
• Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. The means of mains disconnect is to remove the power cord.
• Only use replacement fuse with correct rating (see Table 1 for fuse rating).
• Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE.
• Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide.
• Do not use in an oxygen rich environment.
• To prevent fire or shock hazard, use a replacement power cord of equal rating.
• Do not re-infuse blood or fluid from the canister back into the patient.
• Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. It will reduce service life of the Penumbra ENGINE. Use only waterbased solvents for cleaning.
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Penumbra ENGINE. Otherwise, this could result in degradation of the performance of this equipment.
• Common emitters (such as RFID emitters, security systems, diathermy equipment, and portable transmitters) should not be used in close proximity to the Penumbra ENGINE as they can interfere with and result in degradation of the performance of the equipment.
• Equipment is not safe for MR use.
• No modification of this equipment is allowed.