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
- Pioneered treatment with a PFO-specific device
- Over 100,000 device implanted globally
WE RAISE THE BAR: THE LANDMARK RESPECT TRIAL1
- 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 DEMONSTRATE EXCELLENCE
- ZERO device erosions, thrombus, or embolization events in SIX* published trials with 990 patients1-6
- 94.2% effective closure rates at 6 months1
OFTEN IMITATED, NEVER MATCHED
INDUSTRY-LEADING DEVICE. DEVELOPED SPECIFICALLY FOR THE TREATMENT OF PFO CLOSURE.
DESIGN ADVANTAGES THAT MAKE THE DIFFERENCE
*On commonly used sizes (25mm and 35mm devices)
† Effective closure
ONE STEP AHEAD:
MINIMIZING COMPLEXITY IN CLOSURE
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.
References:
- 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.
- 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.
- 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.