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A landmark device. And a turning point for PFO closure.

Bkg stroke risk pfo

Amplatzer™ PFO Occluder—the leading PFO closure device—demonstrated excellent safety and efficacy in reducing the risk of recurrent stroke in the largest PFO trial ever conducted.

Patent Foramen Ovale (PFO)

By appropriately closing PFOs associated with cryptogenic stroke with the Amplatzer PFO Occluder, physicians can significantly reduce the risk of stroke recurrence.

PFO Occluder 2x

Amplatzer PFO Occluder a pioneering device worldwide

As the device that created the category, the Amplatzer PFO Occluder has sustained leadership over decades of use by pursuing clinical evidence—even beyond an initial study end date—to become the first device supported by positive PFO trial results.1 Today, we continue to innovate around advancing patient safety and reducing risk for patients around the world.

Helping patients live healthy through significant stroke reduction

By appropriately closing PFOs associated with cryptogenic stroke with the Amplatzer PFO Occluder, physicians can significantly reduce the risk of stroke recurrence.

  • Backed by the largest trial with the most extensive patient follow-up
  • Demonstrated excellent safety and efficacy1
  • Industry-leading design for ease of use and effective closure
  • A legacy of excellence across the Amplatzer Occlusion Portfolio, with over 1 million devices successfully implanted worldwide2

Alan’s story

At age 37, Alan went from being a healthy, active individual to having a stroke. Learn how the Amplatzer™ PFO Occluder eased his fears of suddenly having another stroke to living an energetic, hopeful life.

Screenshot 2020 01 08 at 13 56 56 Watch video

Broad inclusion criteria, most extensive follow-up

The landmark RESPECT trial is the largest trial with the most extensive patient follow-up of any trial conducted on PFO closure and its impact on the prevention of recurrent ischemic stroke.

  • The trial enrolled 980 patients at 69 centers across the US and Canada
  • Patients on anticoagulation therapy were not excluded from the trial
  • Patients in the trial were followed for a median of 5.9 years
  • The trial collected a total 5,810 patient-years of data—more follow-up than any other PFO trial
Video animation View animation

How it works Procedure animation

Patent foramen ovale closure with the Amplatzer PFO Occluder

Why is Amplatzer PFO Occluder relied upon by thousands of physicians around the world?

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We set the standard Over 100,000 patients treated worldwide²

  • Over 100,000 patients treated worldwide2
  • Pioneered treatment with a PFO-specific device
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We raise the bar: the landmark RESPECT trial¹

  • 5,810 patient years of data
  • Most extensive patient follow-up, >2X more than other PFO trials
  • Only trial to include patients on anticoagulation therapy, a real-world cross-section of patients
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We demonstrate excellence 990 patients implanted with device in RCTS*

  • 990 patients implanted with device in RCTS*
  • ZERO device erosions, device thrombus, or embolization events in SIX** published trials with 990 patients1-7
  • 93.5% effective closure rates at 6 months8

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 recurrent ischemic stroke

The respect trial
References:

*RCTs=Randomized Clinical Trials
**Patients in device group of each trial implanted with AMPLATZER PFO occluder device: RESPECT = 465, PREMIUM = 119, PC = 191, CLOSE = 121, DEFENSE = 53, PRIMA = 41.
Check the regulatory status of the device in areas where CE marking is not the regulation in force.

  1. 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.
  2. Abbott (2018). Internal Sales Data 1996-2018.
  3. Tobis J, Charles A, Silbertson D, et al. Prospective, randomized investigation to evaluate incidence of headache reduction in subjects with frequent migraine and PFO using the AMPLATZER PFO occluder to medical management. J Am Coll Cardiol 2017; 70:2766-74.
  4. Meier B, Kalesan B, Mattle HP, et al. Percutaneous closure of patent foramen ovale in cryptogenic embolism. N Engl J Med 2013; 368: 1083 – 91.
  5. 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 and supplementary appendix.
  6. Lee PH, Song J-K, Kim JS, et al. Cryptogenic Stroke and High-Risk Patent Foramen Ovale: The DEFENSE-PFO Trial, Journal of the American College of Cardiology (2018), doi: 10.1016/j.jacc.2018.02.046.
  7. Heinrich P. Mattle, Stefan Evers, David Hildick-Smith, et al. Percutaneous closure of patent foramen ovale in migraine with aura, a randomized controlled trial, European Heart Journal, Volume 37, Issue 26, 7 July 2016, Pages 2029–2036.
  8. Carroll JD, Saver JL, Thaler DE, et al. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med 2013; 368: 1092-100.
MAT-2002527 v1.0 | Item approved for OUS use only.