FDA clears AngioScores balloon catheter for renal indications

AngioScore, a developer of angioplasty catheters for use in the treatment of cardiovascular disease, has received 510(k) clearance from the FDA to market its AngioSculpt PTA scoring balloon catheter for dilatation of lesions in renal arteries.

AngioScore previously had received 510(k) clearance to market the AngioSculpt device for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, as well as for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae, according to the Fremont, Calif.-based company. This new 510(k) clearance adds renal arteries to the indications for use statement.

Around the web

The new technology shows early potential to make a significant impact on imaging workflows and patient care. 

Richard Heller III, MD, RSNA board member and senior VP of policy at Radiology Partners, offers an overview of policies in Congress that are directly impacting imaging.
 

The two companies aim to improve patient access to high-quality MRI scans by combining their artificial intelligence capabilities.