A first-in-man experience of the Enabler-P Balloon Catheter System (EndoCross) has shown positive outcomes in the treatment of peripheral artery disease. The results of the study were published in the current issue of the Journal of Endovascular Therapy.
The Enabler-P Balloon Catheter System features a unique balloon-anchoring mechanism and an automated balloon inflation device that allows steady, controlled guidewire advancement by the operator through an occlusion. The new system incorporates increased top force and better pushability of a standard guidewire.
Thomas Zeller, Herz-Zentrum Bad Krozingen, Germany, and colleagues studied 37 patients with a variety of occlusions, including heavily calcified, long, and fibrotic lesions. A successful procedure was achieved in 86% of the overall study population. The average time to successfully navigate the occlusion was 5.3 minutes. Zeller et al reported success in maintaining positioning of the guidewire in the lumen of the blood vessel, even in curvilinear and other challenging areas.
“This novel system, which provides enhanced force to a standard guidewire tip for controlled intraluminal advancement, is a promising device for the treatment of peripheral chronic total occlusions,” the authors wrote.
In a commentary of this study, Carlos Setacci, chief, Department of Surgery, Vascular and Endovascular Surgery Unit, University of Siena, Italy, and colleagues welcome this test of new endovascular techniques and tools. “The work reported by Zeller and colleagues in this issue of JEVT is of the highest caliber and will certainly open new horizons in the treatment of chronic total occlusions in the infrainguinal arteries,” Setacci et al wrote.
Although an increasing number of facilities favor first trying an endovascular approach to obstructed arteries in the leg, there is a lack of adequately designed clinical studies helping to establish these techniques, the authors wrote. Setacci et al note that this new system may offer new possibilities and change attitudes toward lower limb revascularisation in the setting of critical limb ischaemia.
The Enabler-P Balloon Catheter System is CE-marked for use in stenosed and occluded vessels in the lower extremities.