July 18, 2014 — Avinger announced that John Pigott, M.D., of Jobst Vascular Institute, Toledo, Ohio, enrolled the first patient in the VISION trial, a global investigational device exemption (IDE) clinical trial approved by the U.S. Food and Drug Administration (FDA) to evaluate the Pantheris catheter for the treatment of peripheral artery disease (PAD).
The Pantheris system combines directional atherectomy capabilities with real-time intravascular visualization to remove plaque from blocked arteries. The minimally invasive catheter is designed to remove plaque, while avoiding the disruption of normal arterial wall structures.
“While today is a big day for Avinger, it’s 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,” said John B. Simpson, M.D., Ph.D., Avinger founder and CEO. “We designed Pantheris to help physicians better understand what is going on inside the artery as they are treating it. There isn’t a physician on the planet that doesn’t 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 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,” added 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 visualization is immediate and significant,” said VISION co-principal investigators William Crowder, M.D., and J. Gray Bennett, M.D., of St. Dominic Hospital, Jackson, Miss.
For more information: www.avinger.com