Mechanical thrombectomy with a new intermediate balloon catheter combining the BGC and DAC features: Initial clinical experience with the iNedit device

Abstract

Introduction

The iNedit balloon distal access catheter is a novel thrombectomy device. It has an inner diameter of 0.058″, proximal outer diameter of 2.13 mm, and distal outer diameter of 1.67mm. It is compatible with a 0.088″ guide catheter and includes a balloon located 5 cm from the catheter tip, enabling proximal flow restriction and combined therapy with stent retrievers. We investigate the appraisal of the use, safety, and efficacy of the iNedit catheter in the first-in-human study.

Methods

In the preliminary cases that demanded training on the product previous to a multicentric study, prospective data were collected on 22 consecutive patients treated with the iNedit catheter to perform thrombectomy for acute ischemic stroke due to large vessel occlusion within 24 h. The outcome measures consisted of several evaluations of user experience rated on a 5-point scale ranging from 1 (bad) to 5 (excellent), as well as assessments of procedural safety outcomes such as artery perforation and arterial occlusion, procedural efficacy outcomes including first-pass effect (Thrombolysis In Cerebral Infarction [TICI] 2c/3) and final recanalization (TICI 2b/3), and clinical efficacy outcomes such as a 3-month 0–2 modified Rankin Scale (mRS).

Results

The mean age was 72 ± 12 years old; median National Institute Health Stroke Scale was 17 (11–19). Sites of primary occlusion were: 2 internal carotid artery, 12 M1-MCA, 7 M2-MCA, and one P1. Median score evaluation of the appraisal of use was 4- IQR [4–5]. The median number of passes was 1 [IQR 1–2]. First pass complete recanalization rate was 50% and the final recanalization rate was 94.45%. No artery perforation and arterial occlusion. Good functional outcome mRS 0–2 was achieved in 50% of patients.

Conclusions

In this initial clinical experience, iNedit device achieved a high rate of first-pass effect and final recanalization rate with no safety concerns, thus favoring a high percentage of good clinical outcomes.