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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Endovascular 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.
Time frame: 12, 36, 60 months
Successful Coil Embolization Assessed by Angiography
Reduced blood flow to target vessels following coil embolization, assessed by angiography.
Time frame: 12, 36, 60 months
The Frequency of Detachment of Coils During Treatment Procedure
Frequency of successful coil detachment using the EDG v4 during the treatment procedure.
Time frame: Periprocedural
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