Based on the non-clinical testing of the 5.0 mm device using standard views, the worst case maximum artifact was < 4 mm when subjected to 3.0 Tesla. The Pipeline™ Flex embolisation device with Shield Technology™ may create local field inhomogeneity and susceptibility artifacts which may degrade the diagnostic quality of the MRI images. In non-clinical testing, the Pipeline™ Flex embolisation device with Shield Technology™ produced a temperature rise of less than 0.6☌ at a maximum whole body averaged specific absorption rate (SAR) of 4.0 W/kg assessed by calorimetry for 15 minutes of MR scanning in a 3 Tesla MR 750 GE Signa 20.0 System MR Scanner.

Maximum whole-body-averaged specific absorption rate (SAR) of 4.0 W/kg for 15 minutes of scanning.

Spatial gradient field of 720 Gauss/cm or less.Static magnetic field of 3 Tesla or less.It can be scanned safely under the following conditions: Non-clinical testing has demonstrated that the Pipeline™ Flex embolisation device with Shield Technology™ is MR Conditional. Person with known allergy to tin, silver, stainless steel or silicone elastomer may suffer an allergic reaction to the Pipeline™ Flex embolisation device with Shield Technology™ delivery system.Person with known allergy to cobalt/chromium alloy (including major elements of cobalt, chromium, nickel, molybdenum or tungsten) may suffer an allergic reaction to the Pipeline™ Flex embolisation device with Shield Technology™ implant.Use of implants with labeled diameter larger than the parent vessel diameter may result in decreased effectiveness and additional safety risks due to incomplete foreshortening resulting in an implant longer than anticipated.Do not place the Pipeline™ Flex embolisation device with Shield Technology™ in patients whom a pre-existing stent is in place in the parent artery at the target aneurysm location.A thrombosed aneurysm may aggravate pre-existing, or cause new, symptoms of mass effect and may require medical therapy.The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice.Placement of multiple Pipeline™ Flex embolisation devices with Shield Technology™ may increase the risk of ischemic complications.

Do not attempt to re-position the Pipeline™ Flex embolisation device with Shield Technology™ after deployment past the resheathing marker.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.If the catheter cannot be advanced through the Pipeline™ Flex embolisation device with Shield Technology™, carefully remove the delivery wire through the Pipeline™ Flex embolisation device with Shield Technology™ construct.If the delivery wire cannot be retracted into the micro catheter, carefully remove the delivery wire and micro catheter simultaneously.Under fluoroscopy, carefully monitor the tip coil during Pipeline™ Flex embolisation device with Shield Technology™ deployment.The presence of other indwelling endovascular stents may interfere with proper deployment and function of the Pipeline™ Flex embolisation device with Shield Technology™.Advancement of the Pipeline™ Flex embolisation device with Shield Technology™ against resistance may result in damage or patient injury. If high forces or excessive friction is encountered during delivery, discontinue delivery of the device and identify the cause of the resistance, remove device and micro catheter simultaneously.Reprocessing and resterilisation increase the risks of patient infection and may compromise device performance. The Pipeline™ Flex embolisation device with Shield Technology™ is not to be used after the expiration date imprinted on the product label.Carefully inspect the sterile package and the Pipeline™ Flex embolisation device with Shield Technology™ prior to use to verify that neither has been damaged during shipment.

The Pipeline™ Flex embolisation device with Shield Technology™ should be used by physicians who have received appropriate training for this device.This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures at medical facilities with the appropriate fluoroscopic equipment.

Metronic flaticon