Multicenter US clinical experience with the Scepter Mini balloon catheter

Area of Science:

• Interventional Neuroradiology
• Vascular Surgery
• Neurosurgery

Background:

• Liquid embolization of cerebrospinal lesions faces challenges with distal navigability and precise embolic agent delivery.
• The dual-lumen Scepter Mini balloon (SMB) microcatheter was developed to address these limitations.
• Previous small studies suggested favorable outcomes with the SMB microcatheter.

Purpose of the Study:

• To evaluate the safety and efficacy of the Scepter Mini balloon (SMB) microcatheter in endovascular embolization of cerebrospinal lesions.
• To assess technical success rates, procedural complications, and clinical outcomes associated with SMB use.

Main Methods:

• A multi-center retrospective analysis of consecutive patients undergoing SMB-assisted embolization from November 2019 to September 2022.
• Data extracted from prospectively maintained registries across seven North-American centers.
• Included 55 embolization procedures in 54 patients, analyzing procedural details, embolic agents, and follow-up imaging.

Main Results:

• Cranial dural arteriovenous fistulas (54.5%) and arteriovenous malformations (27.3%) were common indications.
• High technical success rates were observed, with 92.5% of cases achieving complete or >50% occlusion at follow-up.
• Low rates of technical failure (5.5%) and SMB-related complications (3.6%) were reported, with no clinical sequelae.

Conclusions:

• The Scepter Mini balloon (SMB) microcatheter is an effective adjunctive device for balloon-assisted embolization of cerebrospinal lesions.
• The SMB microcatheter demonstrates a high technical success rate, favorable patient outcomes, and a reasonable safety profile.
• This multi-center experience supports the utility of the SMB microcatheter in neurointerventional procedures.