Preventing a recurring stroke Close The Patent Foramen Ovale (PFO)
Find out how PFO closure might help your patients
Abbott created the PFO occlusion category, and the Amplatzer™ PFO Occluder has sustained leadership over decades of use and was the first device supported by positive trial results.Treatment options
Reduce their risk of stroke recurrence
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.⁴
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.³About the Amplatzer™ PFO Occluder
We can do better in stroke prevention by using them (Amplatzer PFO) in the appropriate patient.”
- Saver, J.L. Cryptogenic Stroke. NEJM 2016; 374: 2065-74.
- Mojadidi, M.K. et al, Cryptogenic Stroke and Patent Foramen Foramen Ovale. Journal of the American College of Cardiology, Vol 71, No. 9, 2018 1035-42.
- 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
- 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.
- Søndergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017; 377: 1033-42.