Introduction Comaneci is a retrievable coil assist device that is radially adjustable and designed as an adjunct without limiting blood flow.

Aim of Study The objective of this FDA-regulated postmarket study is to assess the safety and performance of the device in US clinical practice.

Methods SUCCESS is a multicenter, single arm, open, prospective study, enrolling 90 consecutive subjects in 17 US centers. Subjects must have a wide neck (4-10 mm or dome to neck ratio <2) intracranial aneurysm, either ruptured or unruptured, that is suitable for coil embolization. Effectiveness endpoints include successful aneurysm occlusion at procedure and 6 months, and clinical outcome at 6 months. Safety endpoints include intraoperative complications.

Results Subjects were enrolled between November 2020 and October 2023 (64% unruptured, 36% ruptured) Overall, a total of 356 coils were used in these cases. Successful Occlusion at end of procedure was 87.8% (N=90), and 81.7% at 6 month follow up (N=71), good clinical outcome (mRS 0-2) was 73% at baseline, 81% at 30 days and 86% at 6 months (P<0.05). Major safety outcomes: Intraoperative thromboembolic events were reported in 5 subjects (5.5%), none were symptomatic; mortality 4.4%, all in ruptured cases; coil entanglement occurred for 1 coil out of the overall 392 coils (0.3%).

Conclusion Interim data demonstrates a high rate of successful aneurysm occlusion when using Comaneci as an assist device in wide neck aneurysms. This effect is sustainable and is accompanied by an improvement in clinical outcome. Safety profile is favorable with low thromboembolic rates.

Disclosure of Interest yes Hanel- Medtronic Consultant Stryker Consultant Cerenovous Consultant Microven4on Consultant Balt Consultant Phenox Consultant Rapid Medical Consultant Q’Apel Consultant MiVI Advisory Board eLum Advisory Board Three Rivers Medical Inc Advisory Board Shape Medical Advisory Board Corindus Advisory Board NIH Research Grant Interline Endowment Research Grant Microven4on Research Grant Stryker Research Grant CNX Research Grant InNeuroCo Investor/Stockholder Cerebrotech Investor/Stockholder eLum Investor/Stockholder Endostream Investor/Stockholder Three Rivers Medical Inc Investor/Stockholder Scien4a Investor/Stockholder RisT Investor/Stockholder BlinkTBI Investor/Stockholder Corindus Investor/Stockholder NTI Investor/Stockholder, Davies - Research Grants: NIH R21/R01, NSF SBIR, UB-CAT, Buffalo Translational Consortium, Cummings Foundation, nVidia, Google Financial Interest: QAS.ai, Rist Neurovascular, Cerebrotech, Synchron, Hyperion Consultant/Advisory Board: Medtronic, Microvention, Imperative Care, Xenter, RapidPulse, Canon, J&J National PI/Steering Committees: StrokeNET DSMB, EMBOLISE, SUCCESS, RapidPulse, SBIR/STTR, NIH NINDS/NLM Study sections.