RT Journal Article SR Electronic T1 Safety of the APOLLO Onyx delivery microcatheter for embolization of brain arteriovenous malformations: results from a prospective post-market study JF Journal of NeuroInterventional Surgery JO J NeuroIntervent Surg FD BMJ Publishing Group Ltd. SP neurintsurg-2020-016830 DO 10.1136/neurintsurg-2020-016830 A1 Philip M Meyers A1 Johanna T. Fifi A1 Kevin M. Cockroft A1 Timothy R. Miller A1 Curtis A. Given A1 Ali R. Zomorodi A1 Bharathi D. Jagadeesan A1 Maxim Mokin A1 Peter Kan A1 Tom L. Yao A1 Orlando Diaz A1 Daniel Huddle A1 Richard J. Bellon A1 Joshua Seinfeld A1 Adam J Polifka A1 David Fiorella A1 Rohan V. Chitale A1 Peter Kvamme A1 Jay T. Morrow A1 Justin Singer A1 Ajay K. Wakhloo A1 Ajit S. Puri A1 Vivek R. Deshmukh A1 Ricardo A. Hanel A1 L. Fernando Gonzalez A1 Henry H. Woo A1 Mohammad Ali Aziz-Sultan YR 2021 UL http://jnis.bmj.com/content/early/2021/01/31/neurintsurg-2020-016830.abstract AB Background Catheter retention and difficulty in retrieval have been observed during embolization of brain arteriovenous malformations (bAVMs) with the Onyx liquid embolic system (Onyx). The Apollo Onyx delivery microcatheter (Apollo) is a single lumen catheter designed for controlled delivery of Onyx into the neurovasculature, with a detachable distal tip to aid catheter retrieval. This study evaluates the safety of the Apollo for delivery of Onyx during embolization of bAVMs.Methods This was a prospective, non-randomized, single-arm, multicenter, post-market study of patients with a bAVM who underwent Onyx embolization with the Apollo between May 2015 and February 2018. The primary endpoint was any catheter-related adverse event (AE) at 30 days, such as unintentional tip detachment or malfunction with clinical sequelae, or retained catheter. Procedure-related AEs (untoward medical occurrence, disease, injury, or clinical signs) and serious AEs (life threatening illness or injury, permanent physiological impairment, hospitalization, or requiring intervention) were also recorded.Results A total of 112 patients were enrolled (mean age 44.1±17.6 years, 56.3% men), and 201 Apollo devices were used in 142 embolization procedures. The mean Spetzler–Martin grade was 2.38. The primary endpoint was not observed (0/112, 0%). The catheter tip detached during 83 (58.5%) procedures, of which 2 (2.4%) were unintentional and did not result in clinical sequelae. At 30 days, procedure related AEs occurred in 26 (23.2%) patients, and procedure-related serious AEs in 12 (10.7%). At 12 months, there were 3 (2.7%) mortalities, including 2 (1.8%) neurological deaths, none of which were device-related.Conclusion This study demonstrates the safety of Apollo for Onyx embolization of bAVMs.Clinical trial registration CNCT02378883.