Dr John Pigott from Jobst Vascular Institute, Toledo, enrolled the first patient in the Vision clinical trial, which received Investigational Device Exemption approval from the US Food and Drug Administration.
Vision is a non-randomized, single arm clinical trial designed to assess the safety and effectiveness of the Pantheris catheter to perform directional atherectomy while using intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries.
As part of the prospective trial, an independent group of physicians will review the angiography results to determine Pantheris’ safety and efficacy.
Pigott said that for the first time ever, he is able to visualize the inside of the artery and selectively remove plaque without disrupting the healthy portion of the vessel.
"This has the potential to revolutionize the treatment of vascular disease," Pigott added.
Avinger said that it has designed the Pantheris catheter to help physicians better understand what is going on inside the artery as they are treating it and the catheter is designed to remove plaque, while avoiding the disruption of normal arterial wall structures.
To remove plaque from blocked arteries, this catheter combines directional atherectomy capabilities with real-time intravascular visualization.
