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About the PFO occluder

About device i Stock 930020910

There are a variety of PFO occluder designs. Many are composed of small metal disks that can be placed in your heart to close the PFO through a minimally invasive, catheter-based technique. A PFO occluder is designed to stop the blood flow and potential clots through the PFO.

Occluder stroke risk 2x

Clinical data overview

One particular 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 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 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 an approved PFO occluder and antiplatelet medication, antiplatelet medication alone, or anticoagulation medication alone. 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.

The respect trial
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-2101847 v1.0 | Item approved for Global OUS use only.

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