With FDA nod, Avinger's PAD device becomes both therapeutic and diagnostic tool

Pantheris device--Courtesy of Avinger

The FDA expanded the indication of Avinger’s image-guided atherectomy device for the treatment of peripheral artery disease, allowing its use in both therapeutic and diagnostic procedures.

Now, the Pantheris device may be used for diagnostic imaging and treatment of PAD simultaneously. It is the first and only image-guided atherectomy system to be cleared for both, according to a statement. In addition to using the device for atherectomy--a catheter-based treatment that removes plaque from a blood vessel--physicians may also use it to identify features of blood vessels, including necrotic cores, fibroatheromas, calcium and stent struts.

Being able to see from inside the artery during an atherectomy procedure facilitates PAD procedures for doctors, Avinger said in the statement. The Lumivascular technology in the Pantheris catheter guides doctors with optical coherence tomography (OCT) imaging while they treat PAD lesions. Previously, physicians had to depend on X-ray images and touch or feel to steer their tools during the procedure.

“The FDA clearance of Pantheris as a diagnostic tool reflects what we as clinicians have already seen first-hand in our practices: that Pantheris OCT images provide important clinical information during our procedures, allowing us to see complicated plaque characteristics in real time as we treat the vessel,” said Dr. Suhail Dohad, an interventional cardiologist with Cedars Sinai Hospital in Los Angeles, in the statement.

Peripheral artery disease affects as many as 9 million people in the U.S., according to the American Heart Association. It refers to narrowed blood vessels that constrict blood flow to the limbs and commonly causes pain in the legs. Other treatments for PAD include Shockwave Medical’s recently cleared angioplasty balloon, which breaks up calcified plaques using ultrasound shockwaves.