BEGIN YOUR JOURNEY TOWARDS PREVENTING CRYPTOGENIC STROKE

If you’ve had a stroke due to an unknown cause, learn how you may be able to prevent another with the Amplatzer™ PFO Occluder.

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UNITED STATES
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Helping Patients Live Healthy Lives Through Significant Stroke Reduction

After pfo closure i Stock 915664860

Clinical studies confirm superiority

Three extensive clinical studies confirm the superiority of PFO closure to medical  management in reducing the risk of stroke recurrence.

 RespectᵃReduceᵇCloseᶜ
Devices used100% Amplatzer™
PFO Occluder
39% Gore® Helex®
61% Gore® Cardioform
51% Amplatzer™ PFO Occluder;
49% approved PFO devices
Patients980664473
Follow-up patient
years
5,810
(median 5.9 yrs)
2,232
(median 3.2 yrs)
Not reported
(median 5.4 yrs)
Anticoaulant allowed
in control group?

Relative risk
reduction
Yes

62%
(Recurrent ischemic stroke
unknown mechanism)
No

77%
(Recurrent ischemic stoke)
Noᵈ

97%
(Recurrent ischemic stroke)
Effective closure 94.2%
Freedom from > 9 bubbles
(Evaluated after 6 months)
94.5%
Freedom from 25 bubbles
(Evaluated after 12 months)
Not reported

Find out why the Amplatzer ™ PFO Occluder is relied upon by thousands of physicians around the world.

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Setting the standard around the world

  • Over 130,000 patients treated worldwide¹
  • Pioneered the treatment with a PFO-specific device
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Raising the bar with the landmark RESPECT Trial²

  • 5,810 patient-years of data
  • Most extensive patient follow-up, >2X more than other PFO trials
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Demonstrating excellence 990 patients implanted with device in RCTS*

  • ZERO device erosions, device thrombus or embolization events in SIX** published trials with 990 patients²⁻⁷
  • 94.2% effective closure rates at 6 months²

Learn more about the RESPECT Trial

Discover 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 strokes.

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.

  1. Internal data. Data on-file at Abbott.
  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. 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.

a. 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.
b. 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.
c. 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.
d. This table focuses on PFO occluder group vs. antiplatelet only group.

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