The panel's decision will be based on data from the TRILUMINATE study, which was ultimately positive for Abbott, but did lead to certain questions about patient outcomes.

Lawrence Phillips, MD, president of the American Society of Nuclear Cardiology, said that U.S. physicians are growing more and more frustrated by Medicare policies.

These new guidelines provide a fresh look at topics ASE has not addressed with official society recommendations in many years. 

The approval, based on positive results from the TRISCEND II trial, represents a significant milestone for the treatment of severe tricuspid regurgitation. 

Heart teams have several options when patients present with stable chest pain and require further testing. According to a brand new analysis of nearly 800 patients, CCTA may be the best place to start. 

According to the FDA, using these devices without following manufacturer recommendations could lead to “serious injuries or death." 

The FDA’s final decision was based largely on positive results from the ADVENT clinical trial, which compared treatment with the Farapulse PFA System to the current standard of care.

The device, which also received Great Britain’s UKCA marking, was specifically designed to be less bulky and easier to wear than other wearable cardioverter-defibrillators.