Avinger Inc (NASDAQ:AVGR) is performing outstandingly well today on news of U.S. Food and Drug Administration (FDA) approval for a new medical device.
The device that is sending Avinger Inc stock soaring with its FDA approval is the Pantheris Lumivascular atherectomy system. This system allows physicians to treat peripheral artery disease in a more accurate way than previous methods.
The Pantheris Lumivascular atherectomy system makes better treatment possible by allowing for real-time intravascular imaging of arteries. This works in combination with catheters to make it easier for doctors to treat peripheral artery disease.
Peripheral artery disease occurs when plaque builds up on artery walls. The Pantheris Lumivascular atherectomy system allows physicians to see directly inside of arteries so that they can better clear them out. Current estimates claim that more than 21 million people in the U.S. will suffer from peripheral artery disease by 2020.
Avinger Inc says that with the recent FDA approval, it is planning to immediately launch its two Pantheris Lumivascular devices in the U.S. It will also be adding these new designs to its INSIGHT IDE clinical trial. This trial is seeking to determine the safety of using Pantheris to treat in-stent restenosis in in lower extremity arteries.
“After extensive testing by our R&D and operations teams, physician design validation, and successful initial case experience in Europe across a variety of different lesion types, we believe this next generation device will significantly improve the user experience in terms of reliability, efficiency, and ease of use across a spectrum of clinical situations,” Jeff Soinski, President and CEO of Avinger Inc, said in a statement.
AVGR stock was up 64% as of Wednesday afternoon.
As of this writing, William White did not hold a position in any of the aforementioned securities.