FDA panel votes against J&J device | Progress for oral heart failure drug | New recalls announced

All 15 members of the FDA's Circulatory System Devices Panel agreed that more data is required to confirm the new device from Johnson & Johnson MedTech is effective. Will the agency agree with these recommendations? Only time will tell.

A clinical trial focused on patients with HFpEF is expected to be completed by July 2026.

Abdominal obesity, the phenomenon commonly known as “beer belly," may be associated with significant risks, including heart failure. Researchers urged cardiologists and radiologists alike to keep these findings in mind going forward.

These most recent recalls focus on a series of maintenance issues. In 2024, the FDA advised customers to transition away from the two devices and find alternative treatment options.

In some cases, researchers noted, cardiologists may need to rely on transcaval access during the treatment of a high-risk heart failure patient. 

The flexible device is attached to the inner wall of the left ventricle during a minimally invasive procedure. It was designed to reduce the size of the left ventricle over time.