524 - Primary Results from a Real-World Registry of the Concerto™ Detachable Coil System for the Treatment of Hemorrhage, Peripheral Aneurysms, and Pelvic Venous Disorders

Purpose: Evaluate safety/effectiveness of Concerto coil system through 12 months in a real-world setting

Materials and Methods: The Product Surveillance Registry enrolled 130 patients at 13 sites embolized with Concerto coil system for indications including arteriovenous malformation, gastric varices, GI bleed, hemorrhoid, pelvic venous disorder/pelvic venous insufficiency (PVD/PVI), peripheral aneurysm, portal vein embolization, trauma bleed, type II endoleak, varicocele, and other. Patients were followed per routine care practice. Safety objectives were non-target tissue ischemia and non-target embolization at index procedure. Performance objectives were technical success, clinical success, target lesion occlusion at follow-up, secondary embolization of target lesion, recanalization, coil compaction, and device fracture.

Results: Indications with ≥10 patients were trauma bleed (30.0%), GI bleed (25.4%), peripheral aneurysm (13.1%), and PVD/PVI (10.8%). Overall 1.3±0.6 lesions were treated per procedure with 3.8±2.6 coils per lesion. Zero instances of non-target ischemia, non-target embolization, and device fracture were reported. Technical success was 97.8%, and clinical success was 97.0%. Target lesion occlusion was mostly maintained for indications with follow-up visits without recanalization or coil compaction (Table 1).

Conclusion: Embolization with the Concerto coil system was safe and effective across a wide variety of indications.