This is a prospective, multicenter, post-market clinical follow-up (PMCF) study to collect safety and performance data in patients with arteriovenous malformations (AVMs) who undergo endovascular coil embolization using the i-ED Coil and Electro Detach Generator v4 (EDG v4).
Subjects aged 18 to <80 years
Subjects requiring endovascular treatment using coils for arteriovenous malformation
Free and informed consent to participate in the investigation obtained from the subject or an acceptable subject representative
Coiling or stenting performed on the non-target lesion within 30 days prior to treatment of the target lesion
Hunt and Hess score of 3 or higher or modified Rankin Score (mRS) of 4 or higher
Subjects with contraindications to CT or MRI procedures
Subjects with contraindications to angiography procedures
Single group
Endovascular Coil Embolization
DeviceEndovascular embolization performed using the i-ED Coil, a detachable platinum coil system, in combination with the Electro Detach Generator v4 (EDG v4).
Post-procedural AVM Occlusion Assessed by Angiography or MRI
Complete or partial obliteration of AVMs assessed by angiography or MRI.
Successful Coil Embolization Assessed by Angiography
Reduced blood flow to target vessels following coil embolization, assessed by angiography.
The Frequency of Detachment of Coils During Treatment Procedure
Frequency of successful coil detachment using the EDG v4 during the treatment procedure.
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