A PIONEERING DEVICE WORLDWIDE

Amplatzer™ PFO Occluder created the category of PFO occlusion, sustained leadership over decades of use, and was the first device supported by positive PFO trial results.

WHY IS AMPLATZER PFO OCCLUDER RELIED UPON BY THOUSANDS OF PHYSICIANS AROUND THE WORLD?

We set the standard

WE SET THE STANDARD

  • Pioneered treatment with a PFO-specific device
  • Over 100,000 device implanted globally1

We raise the bar

WE RAISE THE BAR: THE LANDMARK RESPECT TRIAL2

  • 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

We demostrate excellence

WE DEMONSTRATE EXCELLENCE

  • ZERO device erosions, device thrombus, or embolization events in SIX* published trials with 990 patients2-8
  • 93.5% effective closure rates at 6 months8

OFTEN IMITATED, NEVER MATCHED

INDUSTRY-LEADING DEVICE. DEVELOPED SPECIFICALLY FOR THE TREATMENT OF PFO CLOSURE.

DESIGN ADVANTAGES THAT MAKE THE DIFFERENCE

FPO Occluder Design

*On commonly used sizes (25mm and 35mm devices)
† Effective closure

ONE STEP AHEAD:
MINIMIZING COMPLEXITY IN CLOSURE

One Step Ahead

One Step Ahead

UNIQUE SELF-EXPANDING DISCS:

Linked by a short-connecting waist, the discs align to the PFO without an additional “locking” step.

LOW PROFILE DELIVERY:

8 F & 9 F introducer sheaths for multiple sizes (18, 25, 35 mm) enables treatment of patients with smaller vasculature.

FULLY RECAPTURABLE AND REPOSITIONABLE:

Allows confirmation of device placement prior to final release of the device.

LEARN ABOUT THE PROCEDURE

REFERENCES:

  1. Abbott (2018). Internal Sales Data 1996-2018.
  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.
  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.