PFx Closure System in Subjects With Cryptogenic Stroke, TIA, Migraine or Decompression Illness

The Paradigm IV Trial - PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness

The primary object of this study is to demonstrate the continued safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness.

Inclusion Criteria:

• Age 18 to 65 years old

• PFO with one or more of:

  • Cryptogenic stroke,
  • TIA or embolism,
  • History of severe migraine headaches, or
  • History of severe decompression illness.

Exclusion Criteria:

• In appropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.