The Center for Devices & Radiological Health’s circulatory devices committee plans to review the safety data for St. Jude’s Amplatzer and Gore’s Helex septal occluders. The devices are designed to close holes in the septum between the upper chambers of the heart.
The Amplatzer device, which St. Jude acquired along with AGA Medical $1.03 billion in 2010, was the 1st such device on the U.S. market, with pre-market approval granted in 2001. Gore’s Helex followed in 2006. The FDA is convening today’s meeting to consider adverse events that have become more apparent with growing use.
"With more widespread use of these devices, more information has become available regarding adverse events," according to the FDA announcement. "These events range from rare life-threatening events to more common events that are perceived to have less severe clinical sequelae. Many of these events were evident in the pre-market studies; however, rare events such as erosion were not seen."
The panel will discuss the significance of the new findings in the overall context of the disease and alternative treatments, considering whether additional measures, such as new studies or labeling changes, should be taken in the interest of public health.
ASD devices have gotten mixed reviews lately, including study results released earlier this month finding that the the procedure proved no better at preventing recurring strokes than medication alone.
The study considered now-bankrupt NMT Medical’s StarFlex septal closure system, which won FDA pre-market approval in April 2009. Boston-based NMT began analyzing its closure trial data a year later, reporting in June 2010 that the device failed to meet clinical endpoints.
The newly unveiled study results concluded that, in a comparison of the StarFlex septal closure system with drug therapy against drug therapy alone, there were no statistically significant differences in stroke prevention between the 2 options.
An editorial accompanying the study noted that it took 9 years for the results of the study to be made public, during which time 80,000 patients underwent PFO closure at an average price of $10,000 per procedure, according to a at an average price of $10,000 per procedure.
St. Jude Medical earlier this year announced that it met a stopping rule in its Respect trial examining whether its catheter-based Amplatzer PFO closure device can prevent "cryptogenic" stroke – or strokes with unknown causes. The study met the number of primary events to meet its protocol requirements, which in turn meant that St. Jude could close patient enrollment.