Recanalization of femoropopliteal chronic total occlusions using the ENABLER-P Balloon Catheter System.

PurposeTo evaluate the safety and effectiveness of a new system to facilitate intraluminal advancement of conventional guidewires through chronic total occlusions (CTO) of the superficial femoral artery (SFA) and popliteal artery.MethodsThe ENABLER-P Balloon Catheter System uses a unique balloon-anchoring mechanism and an automated balloon inflation device for steady, controlled advancement of a standard non-hydrophilic guidewire. The system was evaluated in 37 patients (22 men; mean age 67 years (range 41–87) with femoropopliteal CTOs averaging 86 mm in length (range 10–340). The device was used in a variety of occlusions, including heavily calcified, long, and fibrotic lesions. After successful guidewire recanalization facilitated by the system, occluded arterial segments were treated conventionally with balloon angioplasty, atherectomy, and stents as appropriate.ResultsThe primary endpoint of successful crossing was achieved in 86% (32/37) of the overall study population. The average activation time fo...