The FDA’s circulatory devices panel will review post-market data for St. Jude Medical‘s (NYSE:STJ) Amplatzer septal occluder* and W.L. Gore’s Helex septal occluder May 24 to discuss concerns about the devices after more than a decade on the U.S. market.
The pair of catheter-based devices help close atrial septal defects, which occur when a patient has an abnormal hole between the upper chambers of the heart.
St. Jude’s Amplatzer 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 convened the 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 press release.
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.
The St. Paul-based medical device maker bought the Amplatzer technology along with AGA Medical for $1.03 billion in 2010.
Updated April 4, 2012: The St. Jude device being reviewed at the FDA is the Amplatzer septal occluder. This article erroneously stated that it was the Amplatzer cardiac plug.
