December 23, 2016 — The U.S. Food and Drug Administration (FDA) granted a new 510(k) clearance for Avinger’s Lightbox L250 imaging console. It allows detailed measurement of vessels with a few simple taps to a touch screen, helping further improve visualization inside the vessel before, during, and after Pantheris Lumivascular atherectomy procedures for the treatment of peripheral artery disease (PAD). The atheterctomy system offers integrated optical coherence tomography (OCT) intravascular imaging.
In addition, this enhanced technology allows the clinician to create borders and measurements in seconds to determine the area of any vessel feature, automatically generate minimum and maximum diameters within a given area, and generate vessel size measurements for reference vessel sizing to facilitate adjunctive therapies. Users can easily add and move reference points for even greater control.
“The ability to obtain an accurate and real-time measurement from inside a diseased vessel is vital – it provides us key pieces of information that we can use to determine the levels of stenosis and luminal gain both during and immediately after an atherectomy procedure,” said Sean Janzer, M.D., interventional cardiologist from Einstein Medical Center in Philadelphia, Pa. “Additionally, the measurements made possible by this latest upgrade will help optimize both the atherectomy and adjunctive therapies performed post-atherectomy, such as the deployment of a drug-coated balloon or placement of a stent.”
“We are excited to announce this latest FDA clearance, which greatly enhances the ability of the Lightbox L250 to accurately provide vessel measurements, further advancing the potential of Lumivascular technology to dramatically improve patient care,” said John B. Simpson, Ph.D., M.D., Avinger’s founder and executive chairman. “Achievement of this FDA clearance is a key step in our ongoing commitment to ensuring our users have the latest technological advancements at their fingertips for greater confidence and control in treating patients with PAD.”
Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during a directional atherectomy procedure by using OCT, which is displayed on the Lightbox console. In the past, physicians have had to rely solely on X-ray as well as tactile feedback to guide their tools while treating complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, thanks to the real time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionizing radiation.
The new software will be made available to all existing L250 users at no cost and will be incorporated in all future Lightbox products as part of the standard software packages.
For more information: www.avinger.com