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Clinical Insights

PFO Closure or Medical Therapy in Patients with PFO and Cryptogenic Stroke (OUS)

The study concluded that PFO closure plus antiplatelet therapy in CS patients <60 years has the following effects:

  • Compared with APT: A substantial reduction in the risk of ischemic stroke with similar major bleeding risk.
  • Compared with anticoagulation: Similar stroke risk with a modest reduction in major bleeding risk.
  • A modest risk of persistent atrial fibrillation and device or procedure related adverse events compared with APT alone.
PFO Closure or Medical Therapy in Patients with PFO and Cryptogenic Stroke (OUS) (44.11 KB)

The Intaglio Wire Treatment (OUS)

The Intaglio wire treatment reduces the amount of nickel that may be leached from the device by more than 95% depending on the model.

The Intaglio Wire Treatment (OUS) (1750.81 KB)

Piccolo Clinical Trial Summary (OUS)

Clinical trial using the Amplatzer Piccolo™ demonstrated safe and effective PDA closure. Download for more information on the Piccolo Clinical Trial Summary for patients weighing 700 grams and up.

Piccolo Clinical Trial Summary for patients weighing 700 grams and up (OUS) (190.96 KB)

European Position Paper on the Management of Patients. (OUS)

The paper represents the first largely shared, rational position statements on the management of patients with PFO and left circulation thromboembolism, based on the best available evidence.

European Position Paper on the Management of Patients. (OUS) (49.53 KB)
MAT-2006490 v1.0 | Item approved for OUS use only.

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