Vascular Architects Inc has completed sufficient enrollment in its Phase I clinical trial evaluating use of the Vascular Architects aSpire Covered Stent and Controlled Expansion Delivery System for the treatment of iliac and superficial femoral artery (SFA) occlusions to request FDA approval to begin the Phase II clinical trial. Phase I of the trial is being conducted in the U.S. and Europe under an approved Investigational Device Exemption (IDE).
"Completion of sufficient enrollment to begin Phase II of the study represents a major milestone in the company's brief history," stated Bruce Barclay, President and CEO of Vascular Architects. "We are anxious to begin Phase II of the trial following successful completion of the remaining FDA requirements."
In addition to this clinical trial, the Vascular Architects aSpire Covered Stent and Controlled Expansion Delivery System is also currently being clinically evaluated in the U.S. under a second IDE for the treatment of dysfunctional arterio-venous (AV) access grafts.
The aSpire Covered Stent is a spiral nitinol stent completely covered by a thin layer of ePTFE, which provides significantly greater lumen wall coverage than metallic stents. Unlike other covered stent grafts, the aSpire Covered Stent preserves many of the native lumen's desired elements, including the ability to maintain side branch access. It is available in lengths of 2.5, 5.0 and 10 cm and diameters from 6 to 14mm. The aSpire Covered Stent is delivered using Vascular Architects' proprietary Controlled Expansion delivery system.
The company recently reported it has received 510(k) clearance from the U.S. Food and Drug Administration to market the Vascular Architects aSpire Covered Stent and Controlled Expansion Delivery System in the U.S. for treating tracheobronchial strictures. Vascular Architects has also received CE Mark approval to market the device in Europe for the treatment of peripheral vascular disease.