St.Jude Amplatzer® Septal Defect Occluder: What FDA Really Wants

FDA’s circulatory devices panel review meeting last week, a routine scheduled event, has been widely reported as ordering some sort of panic stricken review of St.Jude’s Amplatzer® device.

Closer reading of the minutes reveals a slightly less excitable occasion, the reality being that more widespread use of devices such as this and Gore’s Helex has laid bare rather more clinical evidence for the agency’s panel to have a poke at. In the words of the brief summary of the meeting, which can be found here, “They (the panel) concluded that the overall known safety profile of the class of devices has not changed since marketing approval; however, the awareness of the full spectrum of events/outcomes has been elucidated.”

So no need to panic. But there are a few consequential requirements based on this “spectrum”, namely:

  • Patient follow-up recommendations should be modified. The Panel recommended that since events are more frequent in the first 12 months, there should be frequent follow-up in the first year. Mandatory device tracking was strongly recommended for both devices (Amplatzer and Helex).
  • The current Instructions for Use for the AMPLATZER® device should be modified so that the contraindication related to having a 5 mm anterior-superior aortic rim is clarified and changed to a warning.
  • Both devices should include in the patient and physician labeling a warning regarding patient symptoms that require emergent treatment (e.g., severe chest pain). Also, standard training of echocardiographers, echo laboratories and standard imaging should be captured.
  • There is no need to reanalyse the data collected from the HELEX® studies, however a reanalysis should be performed for the AMPLATZER® data collected.
  • For both devices, the ongoing post approval studies should remain unchanged and agreed that a 522 study is indicated for the AMPLATZER® ASO device(A majority of the Panel members felt that a 522 study for the HELEX device to address fracture issues was not necessary).
  • There should be additional measures taken to ensure that patients are informed of the risks/benefits of transcatheter ASD closure.

The markets are not unduly worried, St.Jude’s price having tracked gently upwards since the announcement.

Source: FDA