The Concerto Versa™ detachable coil is indicated for arterial and venous embolization in the peripheral vasculature.
There are no known contraindications.
The potential complications include, but are not limited to the following: access site complications such as hematoma, hemorrhage, pain; death; device complications such as coil stretching, friction, fracture, breakage, migration, premature detachment, non-detachment; reaction to device materials such as hypersensitivity, fever, shock, foreign body reaction; systemic complications such as infection, pain, shock, fever, inflammation, toxicity, organ failure, nerve damage, necrosis, hypotention, hematoma, hemorrhagic complications, edema; thromboembolic complications such as ischemia, infarction, occlusion, embolism; incomplete or subtherapeutic response; vascular complications such as vasoconstriction, stenosis, dissection, perforation, fistula formation, occlusion.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
Important information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device, at www.medtronic.com/manuals or contact a Medtronic representative.
US-CV-2600919 v1.0
Non-clinical testing and electromagnetic/thermal modeling demonstrated that the Concerto Versa detachable coil is MR Conditional. A patient with this device can be safely scanned in an MR system that meets these conditions:
Under the scan conditions defined above, the Concerto Versa detachable coil is expected to produce a maximum temperature rise of less than 6 °C after 15 min of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends approximately 7.2 mm from the Concerto Versa detachable coil when imaged with a gradient echo pulse sequence and a 3 T MRI system.
US-CV-2600920 v1.0
Find more information, including other available configurations, for Concerto Versa™ detachable coil.
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