The CathPilot: Performance Validation and Preclinical Safety and Feasibility Assessment

Area of Science:

• Vascular Surgery
• Medical Devices
• Endovascular Interventions

Background:

• Peripheral endovascular revascularization procedures face technical limitations affecting success rates.
• Guidewire support, steering, and visualization are critical challenges in these interventions.
• A novel catheter, CathPilot, has been developed to address these limitations.

Purpose of the Study:

• To assess the safety and feasibility of the CathPilot catheter.
• To compare the performance of CathPilot against conventional catheters in peripheral vascular interventions.
• To evaluate the potential of CathPilot to improve procedural outcomes.

Main Methods:

• Comparative study involving CathPilot, non-steerable, and steerable catheters.
• Assessment of target success rates and access times in a tortuous vessel phantom model.
• Evaluation of reachable workspace, guidewire force delivery, and pushability.
• Ex vivo testing on chronic total occlusion samples for crossing success rates.
• In vivo safety and feasibility evaluation in a porcine aorta model.

Main Results:

• CathPilot achieved a 100% target success rate, significantly outperforming conventional catheters (31% non-steerable, 69% steerable).
• CathPilot demonstrated a larger reachable workspace and up to four times higher force delivery and pushability.
• Crossing success rates for chronic total occlusions were 83% (fresh) and 100% (fixed) with CathPilot, exceeding conventional methods.
• In vivo testing confirmed device functionality without adverse events like coagulation or vessel damage.

Conclusions:

• The CathPilot system is safe and feasible for peripheral vascular interventions.
• CathPilot significantly outperformed conventional catheters across all evaluated metrics.
• This technology holds the potential to reduce failure and complication rates, improving overall procedural success and patient outcomes.