Avinger (NSDQ:AVGR) said today that it won 510(k) clearance from the FDA for its Lightbox L250 imaging console. The software is designed to improve visualization inside vessels before, during and after Pantheris Lumivascular atherectomy procedures in patients with peripheral artery disease.
“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,” Dr. Sean Janzer, interventional cardiologist from Einstein Medical Center, said in prepared remarks.”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.”
The console enables clinicians to create borders around vessel features and generate data regarding diameter and area. Users can also generate vessel size measurements for reference vessel sizing, according to Avinger.
“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,” Avinger’s founder & executive chariman Dr. John Simpson said. “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.”