Rx Only: Federal (USA) law restricts this device to sale by or on the order of a physician.
1. Do not use if the pouch is opened or damaged.
2. This device is intended for single use only. Do not reuse, reprocess, or re-sterilize. Reuse, reprocessing or re-sterilization may compromise the structural integrity of the device and/or lead to device failure, which may result in patient injury, illness, or death. Reuse, reprocessing, or re-sterilization 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.
3. After use, dispose of the device in accordance with hospital and/or local government policy.
The APRO®* 55 Catheter and APRO®* 70 Catheter with an aspiration pump and the Alembic Aspiration Tubing are intended 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 tPA) or who fail IV tPA therapy are candidates for treatment. The Alembic Aspiration Tubing is intended to connect the APRO®* 55 Catheter or the APRO®* 70 Catheter to the aspiration pump.
There are no known contraindications.
1. The APRO®* 55 Catheter or the APRO®* 70 Catheter should only be used by physicians who have received appropriate training in interventional techniques and treatment of acute ischemic stroke.
2. The APRO®* 55 Catheter or the APRO®* 70 Catheter is provided sterile and nonpyrogenic. Do not use if the packaging is breached or damaged.
3. Extreme caution should be used if it is required that APRO®* 55 Catheter or the APRO®* 70 Catheter be advanced near or through any aneurysms or other vascular malformations.
4. Do not wedge the tip of the APRO®* 55 Catheter or the APRO* 70 Catheter in the vessel, as this may result in perforation or dissection of the vessel wall.
5. Excessive aspiration with the distal tip of the APRO®* 55 Catheter or the APRO* 70 Catheter covered by the vessel wall may cause vessel injury. Carefully investigate the location of the distal tip under fluoroscopy prior to aspiration.
6. Do not attempt to clear the inner lumen of the APRO* 55 Catheter or the APRO®* 70 Catheter by infusion while keeping the device in the patient. When the flow from the lumen stops or becomes stagnant during aspiration, do not attempt to clear the inner lumen of the APRO®* 55 Catheter or the APRO®* 70 Catheterr by infusion while keeping the device in the patient. Remove the APRO®* 55 Catheter or the APRO®* 70 Catheter from the patient before attempting to clear the lumen.
7. For additional Materials of Concern information, such as REACH, CA Prop 65, or other product stewardship programs, go to www. medtronic.com/productstewardship.
8. Confirm vessel diameter. Do not use the APRO®* 55 Catheter or the APRO®* 70 Catheter in arteries with diameters smaller or equal to the distal outer diameter of the APRO®* 55 Catheter or the APRO®* 70 Catheter.
9. Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.
10. Do not use the device if any damage or irregularities are observed.
11. Hydrate the hydrophilic coating on the APRO®* 55 Catheter or the APRO®* 70 Catheter with heparinized saline before use. Keep the coating hydrated and do not allow the coating to dry
12. Do not over-tighten the hemostatic valve on the sheath or the guide catheter through which the APRO®* 55 Catheter or the APRO®* 70 Catheter is inserted. Overtightening may result in damage to the APRO®* 55 Catheter or the APRO®* 70 Catheter.
13. The introducer sheath is not intended for use inside the patient body. Ensure that the Introducer Sheath is removed from the APRO®* 55 Catheter or the APRO®* 70 Catheter after the distal shaft of the APRO®* 55 Catheter or the APRO®* 70 Catheter is placed inside the patient.
14. Do not advance or withdraw the device if excessive resistance is felt until the cause of resistance is determined.
15. Torquing the APRO®* 55 Catheter or the APRO®* 70 Catheter excessively while kinked may damage the device resulting in separation of the device. If the device is severely kinked, withdraw the entire device (the device, Microcatheter, and Guidewire).
16. Do not exceed a maximum of 3 total passes or a maximum total aspiration time of 5:00 minutes
17. Do not use the device if any damage or irregularities are observed.
18. Do not advance or withdraw the device if excessive resistance is felt until the cause of resistance is determined.
1. The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice.
2. Use prior to the "Use By" date specified on the product package.
3. When using other ancillary devices commonly used in intravascular procedures, refer to the labeling provided with other medical technologies to determine compatibility. The physician must be familiar with percutaneous, intravascular techniques, and possible complications associated with the procedure.
4. Exercise care in handling the APRO®* 55 Catheter or the APRO®* 70 Catheter to reduce the chance of accidental damage
5. Use caution when manipulating the APRO®* 55 Catheter or the APRO®* 70 Catheter in tortuous vasculature to avoid damage. Avoid advancing or withdrawing against resistance until the cause of resistance is determined.
6. The presence of calcification, irregularities, or other devices may damage the APRO®* 55 Catheter or the APRO®* 70 Catheter and potentially affect its insertion or removal.
7. Maintain a constant infusion of an appropriate flush solution. If using a heparinized flush solution, ensure to account for the additional heparin being administered via the flush solution. Failure to do so could result in coagulopathy and excessive bleeding at the access site.
8. When performing aspiration, ensure that the aspiration source is open for only the minimum time needed to remove thrombus. Excessive aspiration or failure to close the aspiration source when aspiration is complete is not recommended.
9. Do not use automated high-pressure contrast injection equipment with the APRO®* 55 Catheter or the APRO®* 70 Catheter as it may damage the device.
10.The catheter distal shaft is hydrophilically coated. Make sure to hydrate the coating with heparinized saline before use. After the catheter is hydrated, do not allow it to dry.
11. Hemostasis valves should be appropriately used throughout the procedure to minimize blood loss. Monitoring of intra-procedural blood loss throughout the procedure should also be performed to ensure that appropriate management may be instituted as necessary.
12. Use the APRO®* 55 Catheter or the APRO®* 70 Catheter in conjunction with fluoroscopic visualization. NOTE: Sufficient shielding, reduced fluoroscopy times, and modified X-ray technical factors should be used when possible, to limit patient and physician exposure to X-ray radiation doses.
13. Do not use if the labeling is incomplete or illegible.
14. Avoid excessive wiping of the coated device to ensure hydrophilic coating is not damaged and fiber particulate is not introduced onto the catheter.
15 .The APRO®* 55 Catheter or the APRO®* 70 Catheter was evaluated for compatibility with agents 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.
16. Carefully inspect all devices prior to use. Verify size, length, and condition are suitable for the specific procedure. Ensure the catheter's labeled outer diameter is smaller than the treatment vessel diameter.
Possible complications include, but are not limited to, the following: •Acute occlusion, lschemia •Unstable angina •Arrhythmia, including ventricular fibrillation •Death •Distal embolization including to a previously uninvolved territory •Emboli •False aneurysm formation •Fever •Access Site Complications (Hematoma or hemorrhage, sterile inflammation, granulomas) •Infection, Sepsis •lntracranial hemorrhage •Hypotension/Hypertension •Acute myocardial infarction •Infarction/Necrosis •Neurological defects including stroke •Vessel spasm, thrombosis, dissection, perforation, rupture •Drug reactions (e.g., coagulopathy, renal insufficiency/failure, allergic reaction) This device is required to be used with fluoroscopy. Potential complications related to angiographic and fluoroscopic X-ray radiation doses include, but are not limited to alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia. The probability of occurrence of complications may increase as procedure time and number of procedures increases.
Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device.
US-NNP-2400086 (v3.0)
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