The cAVM study is conducted at 22 French centers. Patients may be treated by embolization(s) only, embolization(s) + neurosurgery, or embolization(s) + radiosurgery. 

The primary objectives are to evaluate the safety (procedure- or device-related AEs up to 1 month post any embolization session) and performance (recovery rate at 12 months in the embolization 

alone and neurosurgery groups, and at 36 months in the radiosurgery group) of the Onyx® Liquid Embolic System. 

Enrollment was closed in Dec 2016; subject follow-up in the study is ongoing. Final study results are expected in 2021. 

The dAVF study was conducted at 25 French centers to evaluate the safety at 1 month and the performance at 1 month and 3 to 6 months post-embolization with the Onyx® Liquid Embolic System.

Good clinical outcome, indicated by mRS 0-2 changed from 86.8% at baseline to 92.3% at 1-month follow-up after last procedure. Notably, mRS 0 changed from 22% at baseline to 65.9% at 1-month follow-up after last procedure.

At a follow-up of 3-6 months of procedure 1 and 2, 84.7% and 71.4% of patients achieved healing/complete occlusion, 8.2% and 28.6% of patients achieved residual shunt type ≤ IIa; and 6.1% and 0% of patients had residual shunt type > IIa, respectively. Treatment failure was observed in one fistula (1.0%).

Within 1-month post-procedure, 31 CEC-adjudicated procedure- or Onyx™- related AEs were reported in 17.2% of patients. Of these, 30 procedure-related AEs were reported in 17.2% of patients, and 21 Onyx™-related AEs were reported in 11.2% of patients. (Except for one AE in one patient (0.9%), all AEs that were CEC-adjudicated as Onyx™-related were also adjudicated as procedure-related.)

Conclusion:
The results from the dAVF study provide evidence of the safe and efficient treatment of dural arteriovenous fistulae (dAVFs) with Onyx™ embolization. The benefits of treatment are significant and outweigh the risk associated with its use.