Related Experiment Video
Updated: Jul 16, 2026
Myocardial Infarction by Percutaneous Embolization Coil Deployment in a Swine Model
Published on: November 4, 2021
Real-World Safety and Performance of Nylon and PGLA Fibered Detachable Coils in Peripheral Embolization: A
Vincent Wu1, Mina S Makary2, Wyatt Tarter3
1Division of Interventional Radiology, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts, USA.
Purpose:
To evaluate the safety and effectiveness of the Concerto detachable coil system for peripheral embolization in the Product Surveillance Registry (PSR; NCT01524276).
Materials & Methods:
A prospective, multicenter, global observational registry enrolled patients treated with the fibered detachable coil system for arterial or venous embolization. Patients were grouped by disease state and followed up to 12 months. Primary safety and performance objectives included technical and clinical success at index procedure, non-target tissue ischemia or embolization, occlusion of the target lesion, recanalization rate, coil compaction, and device fractures. Secondary objectives were a subanalysis of pain scores based on the Visual Analog Scale (VAS) and Patient Global Impressions Scale for Change (PGI-C) among patients with pelvic venous disorder (PeVD).
Results:
A total of 130 patients were enrolled in this registry across 13 sites. Technical and clinical success of embolization using the fibered detachable coil system was achieved in 97.8% [95% CI: 96.28, 98.77] and 97.0% [95% CI: 93.11, 99.01] of procedures, respectively. Vessel occlusion rate was 100% at 12-months post intervention. No cases of non-target tissue ischemia, non-target embolization, target vessel recanalization, or device fracture were observed. A subanalysis of the PeVD cohort demonstrated a reduction in VAS pain scores. PGI-C was improved overall from the 30-day to the 12-month follow-up.
Conclusions:
The fibered detachable coil system demonstrated safe and effective performance across multiple peripheral vascular embolization disease states in real-world clinical practice.
