Avinger announces new FDA clearance for Lumivascular imaging console


Avinger has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Lightbox L250 imaging console. Avinger says that with this new FDA clearance, the Lightbox L250 now provides detailed measurement of vessels using a touch screen, helping improve visualisation inside the vessel before, during, and after Pantheris Lumivascular atherectomy procedures for the treatment of peripheral artery disease.

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,” a company press release states.

“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, interventional cardiologist from Einstein Medical Center in Philadelphia, USA. “Additionally, the measurements made possible by this latest upgrade will help optimise 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, 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 peripheral artery disease.”

Avinger says that 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.