Dozens of customers have reported issues with the device’s balloon or catheter hub separating from the delivery system, mostly during off-label use in a patient's blood vessels.

Catch up on several recent FDA announcements, including an update on the agency's response to the COVID-19 pandemic. 

Long-term mortality, meanwhile, is similar between the two treatment options.

Researchers aimed to shine light on this key topic, tracking data from nearly 200,000 patients. 

"For clinicians, suspicion for valve diseases should be increased and evaluations carefully performed for patients with MAC," according to one Mayo Clinic cardiologist.

The drug-coated balloon was approved to treat patients with peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries