“We believe this case is potentially groundbreaking," one interventional cardiologist said. 

The devices, currently being investigated by teams of heart specialists, could make a big impact in the years ahead. 

While the system used during the procedure has not yet gained full FDA approval, this patient was treated under a compassionate-use clearance from the agency.

Customers have been asked to return all unused devices and pause any new clinical trials involving the Harmony TPV. 

The trial is expected to enroll up to 650 patients from as many as 100 different facilities throughout the world.

The study's authors compared findings from the PROTECT-AF and PREVAIL clinical trials with data from the NCDR LAAO Registry, focusing on short-term and long-term outcomes. 

A new analysis found that 30-day outcomes do not significantly change when LAAO patients go home the same day as their procedure. 

The median time from heart valve implantation to balloon dilatation was 4.6 months.