For patients who have had a cryptogenic stroke and have a patent foramen ovale (PFO), clinical trials have shown that they can benefit from PFO closure.2-4
The Amplatzer™ PFO Occluder significantly lowers the risk of recurrent ischemic stroke and offers an excellent safety profile.1
PFO Trials Represent a Turning Point
Three large clinical trials have confirmed the superiority of PFO closure to medical management in reducing risk of stroke recurrence.2-4
One study, the RESPECT trial,2 is notable for several reasons:
- Excellent safety and efficacy outcomes from the largest PFO trial to date
- More patients enrolled and evaluated
- The most extensive patient follow-up: 5,810 patient years of data
First on the Market, Still First Worldwide
The Amplatzer PFO Occluder set the standard, pioneering treatment with a device developed specifically for PFO closure. Such leadership is one reason physicians can rely on the Amplatzer PFO occluder, since:
- As an industry-leading design, it facilitates easy closure
- Over 130,000 devices have been implanted worldwide1
MAT-2010605 v1.0 | Item approved for Global OUS use only.
- Data on file at Abbott.
- 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;377:1022-1032. doi: 10.1056/NEJMoa1610057.
- Søndergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017;377:1033-1042. doi: 10.1056/NEJMoa1707404.
- Mas J-L, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017;377:1011-1021 and supplementary appendix. doi: 10.1056/NEJMoa1705915.