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About the Amplatzer™ PFO Occluder

About device i Stock 930020910

The Amplatzer™ PFO Occluder consists of two nitinol wire mesh discs that can be placed in your heart to close the PFO through a minimally invasive, catheter-based technique. The PFO occluder is designed to stop the blood flow and potential clots through the PFO.

Amplatzer™ PFO Occluder
PFO closure procedure for stroke risk reduction

Clinical data overview

The Amplatzer™ PFO Occluder was studied in the RESPECT Trial in the US and Canada. The trial enrolled 980 patients, between the ages of 18 to 60, who were diagnosed with a PFO and a cryptogenic stroke. Patients were randomly assigned to either receive the Amplatzer™ PFO Occluder plus blood-thinning medication, or blood-thinning medication alone. The patients were assessed at 30 days, six months, one year and yearly thereafter. The RESPECT Trial was designed to evaluate whether PFO closure with the Amplatzer™ PFO Occluder plus blood-thinning medication was more effective in reducing the risk of another ischemic stroke compared with the sole use of blood-thinning medication. Over a median follow-up period of 5.9 years, the rate of recurrent ischemic stroke was 45% lower with PFO closure compared to medical management exclusively.²

In the CLOSE Trial, 663 patients received either the Amplatzer™ PFO Occluder or another approved PFO occluder. This trial showed a 97% stroke risk reduction in patients who underwent PFO closure plus antiplatelet therapy compared to patients who received antiplatelets only.¹

Rate of new stroke in the RESPECT trial

The results of the RESPECT Trial analysis, which was conducted when the average follow-up was about five years, suggested that if 1,000 patients were treated with PFO closure, about six of these patients would have a stroke after one year compared to about 10 out of 1,000 patients treated with blood-thinning medication alone. That’s a 45% relative risk reduction of recurrent stroke for patients who had their PFO closed compared to people who just took blood-thinning medication.²

What happens after the PFO Closure procedure?

Learn about the post-procedure care plan.

Read more

Learn more about the respect trial

Read more about the largest trial with the most extensive patient follow-up of any trial conducted on PFO closure and its impact on the prevention of another ischemic stroke.

References
  1. Mas J-L, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017; 377: 1011-21.
  2. Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017; 377: 1022-32.
  3. Internal data. Data on-file at Abbott.
MAT-2003150 v3.0 | Item approved for OUS use only.

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