Abstract TP161: Embolization Of Intracranial Aneurysms Using WAVE Extra Soft Coils, A Part Of The Penumbra SMART COIL System: An Interim Analysis Of The SURF Study

Abstract

Introduction: Initial clinical evidence has shown that coiling with the SMART COIL System (Penumbra, Inc.) is a safe and durable treatment option for intracranial aneurysms. The SURF study is a post-market, prospective, multicenter, single-arm, observational study to assess the utility of the WAVE Extra Soft Coil (WAVE) as fill and finishing coil to support adequate occlusion of intracranial aneurysms. Methods: Enrollment began November 5, 2019; this analysis includes data as of July 20, 2021. Patients undergoing embolization of intracranial aneurysms with WAVE as the final finishing coil and Penumbra SMART COIL System accounting for at least 75% of the total number of coils implanted were enrolled consecutively at 34 centers globally. Post-procedure Raymond Roy Occlusion Classification (RROC) was assessed by a core lab. The estimated enrollment will be 800 patients. Results: This analysis includes 346 patients, mean age 60.1 (SD 13.03), 73.1% female. Of the target aneurysms, 39.8% (135/339) were ruptured, and 80.5% (269/334) were saccular, and 11.5% (39/338) were previously treated. Post-procedure, 89.2% (206/231, 95% CI 85.2%, 93.2%) of aneurysms were RROC I or II. Device-related SAEs occurred in 1.5% (5/346, 95% CI 0.2%, 2.7%) of patients up to 7 days or discharge. The rate of major ipsilateral stroke was 0.6% (2/346), and the intra-procedural rupture rate was 0.6% (2/346). Conclusions: We report interim outcomes from the SURF study. This post-market registry evaluates the safety and performance of the Penumbra SMART COIL System, including WAVE as fill and finishing coil, in the treatment of intracranial aneurysms.