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First-in-Man Results Show Utility for Novel PAD System
A new system that allows intraluminal advancement of conventional guidewires through chronic total occlusions of the superficial femoral artery and popliteal artery was associated with successful crossing in more than 85% of patients in a first-in-man study.
In the study, a novel balloon catheter system (ENABLER-P, EndoCross) was tested in 37 patients with femoropopliteal CTOs, which included heavily calcified, long and fibrotic occlusions.
The primary endpoint of device success, defined as successful guidewire crossing, was achieved in 86% of patients. Following recanalization, the overall rate of treatment success was 92%. The researchers also reported one (3%) device-related complication in a case in which the wire was advanced into a side branch during treatment of a 300-mm long flush ostial superficial femoral artery occlusion.
For more information:
Zeller T. J Endovasc Ther. 2012;19:131-139.
Robert S. Dieter
Dr. Zeller and colleagues present the results of a new femoropopliteal CTO balloon catheter system that facilitates true luminal crossing of chronic CTOs. The system involves a balloon catheter that helps with centering and anchoring. A pressure control unit then inflates and deflates the balloon, and with each inflation the balloon elongates and advances the wire up to 3 mm. The balloon remains stationary, but continues to cycle to slowly advance the wire through the CTO. The researchers had an overall 86% success rate with this system and a 3% rate of device-related complications. This is a novel mechanism that adds to the armamentarium for the treatment of CTOs.
– Robert S. Dieter, MD, RVT
Cardiology Today Intervention Editorial Board member
Disclosure: Dr. Dieter reports no relevant financial disclosures.