The U.S. Food and Drug Administration (FDA) has announced on March 20 that Bard Peripheral Vascular updated its instructions for use for Rotarex Atherectomy Systems after receiving reports of helix fracture or breakage.

According to the company, certain patient anatomical characteristics and procedural factors have been identified as potential contributing factors in helix fracture or breakage events.

Access the FDA website for more on specific updates made to the instructions for use and additional agency and company resources.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery

Keywords: United States Food and Drug Administration, ACC Advocacy, Atherectomy, Arteries