SOCRATES® 38
Aspiration Catheter
Socrates® 38 Aspiration Catheter is the first fully microfabricated aspiration catheter indicated for the revascularization of patients with acute ischemic stroke.
Built on the revolutionary technology that propelled the Aristotle guidewires to the forefront of neurovascular devices, Socrates® 38 provides physicians with an innovative tool designed for quick access and efficient treatment of ischemic stroke.
The Socrates® 38 aspiration advantage
Successful outcomes rely on lumen diameter integrity not just at the tip, but throughout the entire catheter body. With Socrates® 38, thousands of nitinol rings create a uniform lumen along the length of the catheter, delivering a consistent aspiration force end-to-end.
The precise fit between the Socrates® 38 Aspiration Catheter and the Aristotle® Colossus Guidewire goes beyond compatibility; it represents Scientia’s intention in developing guidewires and catheters that are systematically created to minimize ledge effect and enable a smoother navigation to the clot face.
Successful aspiration outcomes are related to minimizing the distance of the catheter tip to the clot. The nitinol exoskeleton on Socrates® 38 articulates through the vasculature, translating a heightened push response throughout the catheter body. Greater trackability could aid in achieving a closer distance to the clot and enhanced thrombectomy success.
Removal of clot is dependent on the functional integrity of the catheter. The elastic property of nitinol enables Socrates® 38 to avoid permanent deformations, facilitating multiple aspiration passes at maximum capability. This could reduce overall procedure costs incurred through utilizing replacement devices.
The microfabricated nitinol body of the Socrates® 38 Aspiration Catheter resists undesirable rotation, resulting in a more centered pathway while traversing challenging anatomy. This design results in a more efficient path through the vasculature and promotes an ideal interaction between the clot face and catheter tip.
Elevating stroke care through microfabricated precision
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Scientia Vascular: pioneering better outcomes
Socrates® 38 Aspiration Catheter (156 cm) | Socrates® 38 Aspiration Catheter (127 cm) | Socrates® Aspiration Tubing | |
---|---|---|---|
Product ref | SC038-156-001 | SC038-127-001 | TS-254-110 |
Outer diameter | 4 French 0.053 in 1.35 mm | 4 French 0.053 in 1.35 mm | N/A 0.188 in 4.78 mm |
Inner diameter | 0.038 in 0.97 mm | 0.038 in 0.97 mm | 0.11 in 2.79 mm |
Working length | 61.4 in 156 cm | 50.0 in 127 cm | 100 in 254 cm |
Hydrophilic coating length | 90 cm | 90 cm | N/A |
Minimum guiding catheter ID | 0.058 in 1.47 mm | 0.058 in 1.47 mm | N/A N/A |
Maximum guidewire diameter | 0.035 in 0.89 mm | 0.035 in 0.89 mm | N/A N/A |
Indications for use
As part of the Socrates® Aspiration System, the Socrates® 38 Aspiration Catheter with a compatible suction pump 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, basilar, and vertebral arteries) within eight 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.
As part of the Socrates® Aspiration System, the Socrates® Aspiration Tubing is indicated to connect the Socrates® 38 Aspiration Catheter to a compatible suction pump.
Contraindications
None known.
Warnings and precautions
- The Socrates® Aspiration System should be used only by physicians with a thorough understanding of angiography and/or percutaneous interventional procedures and treatment of acute ischemic stroke.
- Do not use in arteries with diameters smaller or equal to the outer diameter of the Socrates® 38 Aspiration Catheter. Refer to the table above for dimensional information.
- Carefully inspect the catheter prior to use to verify the size and condition are suitable for the specific procedure and for any damage such as kinks or bends. Any damage may decrease performance resulting in patient injury or death.
- For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
- The Socrates® Aspiration System is supplied STERILE and non-pyrogenic for single use only. Inspect the pouch prior to use for any gaps in sterile barrier such as faulty seals or holes. Do not use if sterile barrier is damaged or package is opened. Do not reprocess or re-sterilize. Reprocessing or resterilizing increases the risks of patient infection and compromises device performance.
- The Socrates® 38 Aspiration Catheter tips are not steam shapeable.
- Do not perform more than three (3) clot retrieval attempts with the Socrates® Aspiration System.
- Avoid wiping the device with gauze as this may damage the device coating.
- Avoid excessive wiping of the coated device.
- Avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the device because this may cause unpredictable changes in the coating, which could affect the device safety and performance.
- Avoid pre-soaking devices for longer than instructed, as this may impact the coating performance. Never advance or withdraw any device within the catheter against resistance until the cause of the resistance is determined.
- Discontinue use of catheter for infusion if increased resistance is noted. Resistance indicates possible blockage. Remove and replace blocked catheter immediately. Do not attempt to clear blockage by over-pressurization. Doing so may cause the catheter to rupture, resulting in vascular damage or patient injury.
- The Socrates® 38 Aspiration Catheter should be manipulated under fluoroscopy. Do not attempt to move the catheter without observing the resulting tip response. Movement of the catheter against resistance may result in damage to the catheter or injury to the patient.
- The Socrates® 38 Aspiration Catheter should not be used with automated high-pressure contrast injection equipment as it may damage the device or injure the patient.
- The Socrates® 38 Aspiration Catheter has not been evaluated for compatibility with stent retriever devices and should not be used in combination with stent retrievers, as the combined use could damage the catheter or result in patient injury.
- When performing aspiration, ensure that the Socrates® Aspiration Tubing clamp is open for only the minimum time needed to remove the thrombus. Do not aspirate for more than 300 continuous seconds (5 minutes) when no clot is engaged with the catheter. Excessive aspiration or failure to close the Socrates® Aspiration Tubing clamp when aspiration is complete can result in device malfunction
Precautions
- Use the devices prior to the “Use By” date specified on the package.
- Limit exposure to X-ray radiation doses to patients and physicians by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors when possible.
- Maintain a constant infusion of appropriate flush solution.
- Administration of anticoagulants and antiplatelets, medical management, and acute post stroke care should follow hospital guidelines. Any neurological deterioration should be evaluated by urgent CT scan and other evaluations as indicated according to investigator/hospital best practices.
- The Socrates® 38 Aspiration Catheter was evaluated for compatibility with solutions that include contrast media and heparinized saline. The use of these catheters for delivery of solutions other than the types that have been tested for compatibility has not been evaluated.
- Socrates® aspiration catheters are not safe for use in or near Magnetic Resonance Imaging (MRI) equipment.
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