Clinical Background

ENABLER Syatem versus common practice

ENABLER System versus common practice

Chronic Total Occlusions (CTO) are considered the most challenging arterial lesions and are commonly referred to as the final frontier of angioplasty.

CTOs of the lower extremities often result in Critical Limb Ischemia (CLI) and claudication, impacting the lives of millions. The ability to successfully traverse and recanalize CTOs is therefore imperative. Attempts at recanalization, especially in heavily calcified lesions, often fail when using traditional guidewires and existing technology.

The safety and effectiveness of the ENABLER-P System in crossing chronic total occlusions has been investigated in a multicenter clinical study. The system was found to be safe and achieved high crossing rates (86.4%) with no major adverse events.

The results of the study have been published in the Journal of Endovascular Therapy (2012 Apr;19(2):131-9) for the abstract see;  Recanalization of femoropopliteal chronic total occlusions using the ENABLER-P Balloon Catheter System.

Following clinical use, the system was described by physicians as a user friendly device that enables straight forward crossing of occlusions.