Avinger has announced that John Pigott of Jobst Vascular Institute, Toledo, USA has enrolled the first patient in VISION. VISION is a global investigational device exemption (IDE) clinical trial, approved by the FDA, to evaluate Avinger’s Pantheris catheter for the treatment of peripheral artery disease.
The Pantheris system combines directional atherectomy capabilities with real-time intravascular visualisation to remove plaque from blocked arteries. The minimally invasive catheter is designed to remove plaque, while avoiding the disruption of normal arterial wall structures. Despite other attempts in the industry, this has never been accomplished until now.
“While today is a big day for Avinger, it is an even bigger day for physicians and hospitals looking for better ways to treat patients suffering from vascular disease. Today we are one step closer,” says John B Simpson, Avinger’s founder and chief executive officer. “We designed Pantheris to help physicians better understand what is going on inside the artery as they are treating it. There is not a physician on the planet that does not want more information about their patients’ disease state with the ability to act on it in real time.”
“For the first time ever, I am able to visualise the inside of the artery and selectively remove plaque without disrupting the healthy portion of the vessel. This has the potential to revolutionise the treatment of vascular disease,” says John Pigott.
“We are convinced that Avinger’s Pantheris catheter will be a major step forward for our patients and for the entire medical community as the increased precision allowed by direct visualisation is immediate and significant,” say VISION co-principal investigators William Crowder and J Gray Bennett of St Dominic Hospital, Jackson, USA.