FDA News

Imaging console cleared for use in procedures to treat PAD

Avinger announced it received FDA clearance for an imaging console to assist clinicians during atherectomy procedures for treatment of peripheral artery disease.

The console (Lightbox L250) enables detailed measurement of vessels by OCT via a few taps on a touchscreen, which can improve visualization inside the vessel before, during and after treatment with a directional atherectomy system (Pantheris Lumivascular), according to a press release.

Previously, clinicians relied on X-ray and tactile feedback to guide tools during such procedures, the company stated in the release.

“The ability to obtain an accurate and real-time measurement from inside a diseased vessel is vital — it provides us key pieces of information we can use to determine the levels of stenosis and luminal gain both during and immediately after an atherectomy procedure,” Sean Janzer, MD, an interventional cardiologist at Einstein Medical Center, Philadelphia, said in the release. “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.”

Disclosure: Janzer reports consulting for Avinger.

 

 

Avinger announced it received FDA clearance for an imaging console to assist clinicians during atherectomy procedures for treatment of peripheral artery disease.

The console (Lightbox L250) enables detailed measurement of vessels by OCT via a few taps on a touchscreen, which can improve visualization inside the vessel before, during and after treatment with a directional atherectomy system (Pantheris Lumivascular), according to a press release.

Previously, clinicians relied on X-ray and tactile feedback to guide tools during such procedures, the company stated in the release.

“The ability to obtain an accurate and real-time measurement from inside a diseased vessel is vital — it provides us key pieces of information we can use to determine the levels of stenosis and luminal gain both during and immediately after an atherectomy procedure,” Sean Janzer, MD, an interventional cardiologist at Einstein Medical Center, Philadelphia, said in the release. “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.”

Disclosure: Janzer reports consulting for Avinger.