The CathPilot: Usability and Feasibility Evaluation in Simulated-Use Endovascular Interventions.

Area of Science:

• Endovascular Surgery
• Medical Device Innovation
• Interventional Cardiology

Background:

• Complex peripheral artery disease and chronic total occlusions present significant endovascular treatment challenges.
• Limited distal device control and reliance on proximal manipulation with conventional catheters hinder procedural success.

Purpose of the Study:

• To evaluate the procedural usability and effectiveness of the novel CathPilot steerable catheter.
• To compare the CathPilot system against conventional non-steerable catheters in simulated complex lesion crossing.

Main Methods:

• A within-subjects design study involving eight interventional clinicians.
• Simulated lesion crossing in a silicone phantom model of the superficial femoral artery using CathPilot and conventional catheters.
• Objective (success rate, time, radiation) and subjective (usability, workload) endpoints were assessed.

Main Results:

• CathPilot achieved a 92% lesion-crossing success rate, a threefold improvement over conventional catheters.
• Significantly reduced procedure and fluoroscopy times were observed with CathPilot.
• Lower operator workload ratings (NASA-TLX) were reported for the CathPilot system.

Conclusions:

• The CathPilot system demonstrates significant potential to overcome endovascular revascularization challenges.
• Precise distal tip control, tracking, and support offered by CathPilot enhance procedural outcomes and usability.
• This technology represents a valuable advancement for treating complex peripheral artery disease.