Post-Market Clinical Follow-up Study of i-ED Coil and EDG v4 for Arteriovenous Malformation

Safety and Efficacy of i-ED Coil and EDG v4 for Arteriovenous Malformation - A Prospective Study

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).

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Pregnant or breastfeeding subjects