The FDA has said this is a Class I recall, which means using the devices “may cause serious injuries or death.” A total of 18 injuries have been reported so far. 

The new device was designed to remove thrombi and emboli from peripheral arteries ranging from 2 to 4 mm. 

After warning healthcare providers about a heightened risk of mortality back in 2019, the FDA has now updated its stance on the use of these devices. 

The primary concern is that sterilization facilities and healthcare providers would not have enough time to adapt to the proposal. Devices impacted would include pacemakers, angioplasty balloons and catheters, just to name a few. 

Three cardiology societies have reached out to CMS with questions about how MACs are interpreting a policy related to shared decision-making. 

The new-look DCB was designed to provide care with a significantly lower drug load than similar devices. 

Researchers in Japan tracked BNP levels and bleeding events among more than 7,000 PCI patients. The group noted that managing heart failure in the first 30 days after PCI can help boost outcomes. 

Dense calcifications have long been viewed as one of the most challenging aspects of TLE procedures. IVL may offer specialists a new way to address that issue.