Safety & Effectiveness of the Obtura 8F Vascular Closure Device in Neuro-Interventional Practice: A Retrospective Analysis

Abstract

Objective

Vascular closure devices (VCDs) are essential in modern neuro-interventional procedures, offering advantages over manual compression by accelerating hemostasis, reducing complications, and enabling early ambulation. The Obtura 8F VCD is a novel bioabsorbable closure device designed to enhance safety and procedural efficiency. This study evaluates its efficacy and safety in achieving hemostasis and preventing vascular complications following femoral artery access.

Method

This retrospective, single-center study analyzed patients who underwent femoral artery closure with the Obtura 8F VCD. The primary performance endpoint was a successful hemostasis without additional intervention. The primary safety endpoint was the incidence of vascular complications within 30 days and 3 months. Secondary outcomes included time to ambulation and length of hospital stay.

Results

A total of 100 patients (mean age: 59.48 ± 13.03 years, 64% male) were included. Hemostasis was successfully achieved in 96% of cases, and all patients were able to move the limb within 8 hours post-procedure. During hospitalization, hematoma/pseudoaneurysm occurred in 6% of patients, with age ≥65 years, hypertension, and diabetes identified as significant risk factors. No evidence of infection was reported at either 30 days or 3 months. The majority of patients (80%) were discharged within 4-7 days.

Conclusions

The Obtura 8F VCD demonstrated high efficacy in achieving hemostasis with a strong safety profile with no major vascular complications. These findings support its use as a reliable alternative to manual compression, facilitating faster patient recovery and potentially reducing hospital resource utilization.