Clinical and Haemodynamic Evaluation of a Novel Physician Modified Inner Branch Iliac Branch Device for East Asians

Introduction: The anatomic suitability of the iliac branch device remains limited, particularly in East Asians, in whom the common iliac arteries (CIAs) are notably short. This study aimed to evaluate the safety and haemodynamic effects of the physician modified inner branch iliac branch device (PM-IIBD) via clinical outcomes and computational fluid dynamics (CFD) analysis. Method: In this observational case series study, clinical safety was evaluated in ten patients treated with the PM-IIBD for internal iliac artery preservation. CFD analyses were performed before surgery and at 12 month follow up to compare haemodynamic changes in four CIA regions. CFD parameters included velocity, pressure, time averaged wall shear stress (TAWSS), relative residence time, oscillatory shear index (OSI), energy loss, and flow distribution ratios. Conclusion: Preliminary clinical and CFD analyses have demonstrated the efficacy and haemodynamic stability of the PM-IIBD. By reducing spatial demands on the CIA, the PM-IIBD expands anatomic suitability, offering a feasible solution for internal iliac artery preservation in East Asians.