Recanalization of femoropopliteal chronic total occlusion susing the ENABLER-P balloon catheter system

ABSTRACT

Purpose: To evaluate the safety and effectiveness of a new system to facilitate intraluminaladvancement of conventional guidewires through chronic total occlusions (CTO) of thesuperficial femoral artery (SFA) and popliteal artery.Methods: The ENABLER-P Balloon Catheter System uses a unique balloon-anchoringmechanism and an automated balloon inflation device for steady, controlled advancementof 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 thesystem, occluded arterial segments were treated conventionally with balloon angioplasty,atherectomy, and stents as appropriate.Results: The primary endpoint of successful crossing was achieved in 86% (32/37) of theoverall study population. The average activation time for successful crossing was5.3 minutes (range 0.4–22). Of the 32 cases successfully crossed with the ENABLER-PSystem, all but 1 was successfully recanalized. One (3%) device-related complicationoccurred when the wire was advanced into a side branch when treating a 300-mm-longflush ostial SFA occlusion; the resulting perforation was managed with a covered stentwithout further sequelae.Conclusion: This novel system, which provides enhanced force to a standard guidewire tipfor controlled intraluminal advancement, is a promising device for the treatment ofperipheral CTOs.