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STRUCTURAL INTERVENTIONS

AMPLATZER™
PFO OCCLUDER

For patients who have experienced a PFO-associated stroke, clinical trials have shown that they can benefit from PFO closure.2-4 This minimally-invasive procedure significantly reduces the risk of recurrent ischemic stroke and offers an excellent safety profile.

THE PIONEER 
IN PFO CLOSURE1

As the device that created the category, the Amplatzer™ PFO Occluder has sustained leadership over decades of use by pursuing clinical evidence to become the first device supported by positive PFO trial results.2

Today, it is the most-studied device of its kind, with over 180,000 patients treated worldwide.1 And our clinical evidence is unmatched, thanks to the largest-ever trial for PFO closure, boasting 5,810 patient-years of data.2

Amplatzer PFO Occluder is the first device supported by positive patent foramen ovale trial results

The PFO Occluder trusted by thousands of physicians around the world1

180K+

Global implants1


WE SET THE STANDARD

  • For over 20 years, the most-studied and most-trusted device of its kind.
  • Pioneered treatment with a PFO-specific device
  • Available in over 80 countries around the world

5,810

PATIENT-YEARS OF DATA2


WE RAISE THE BAR

  • With the landmark RESPECT trial,2 we had the most extensive patient follow-up, almost 2x more than other PFO trials
  • RESPECT was also the only trial to include patients on anticoagulation therapy, a real-world cross-section of patients

990

PATIENTS IMPLANTED WITH DEVICE IN RCTS2-4


WE DEMONSTRATE EXCELLENCE

  • ZERO device erosions, thrombus, or embolization events in 6 published trials with 990 patients
  • 94.2% effective closure rate at 6 months

How to implant the Amplatzer
PFO Occluder

Watch the Amplatzer PFO Occluder implant procedure video.

The Amplatzer PFO Occluder is a percutaneous, transcatheter occlusion device intended to close all types of PFOs (i.e. classical, as well as those with aneurysm of the septum) in patients with a history of stroke or transient ischemic attacks (TIAs) diagnosed by echocardiography with right-to-left shunting during the Valsalva maneuver.

Among patients with a PFO who have had an ischemic stroke, the Amplatzer PFO Occluder has demonstrated excellent safety and effectiveness in reducing the risk of recurrent stroke.

Key benefits for PFO patients

59% RELATIVE RISK REDUCTION IN RECURRENT ISCHEMIC STROKE5

LESS ANXIETY, MORE PEACE-OF-MIND

For patients who have experienced a PFO-associated stroke, the thought of a recurrence can generate anxiety. Determining and delivering the most effective treatment soon after a stroke is critically important to provide these patients with peace-of-mind.

For patients and caregivers wanting to learn more about PFO-associated stroke and PFO closure, www.PFOstroke.com is an excellent resource, including:

  • All about PFO and stroke
  • Understanding PFO treatment options
  • Information about PFO occluders
  • Resources, including FAQ and brochures
     

Back to walking 12 miles per day

Alan Whitstable - England

As an employee of the Royal Mail postal service “I’m back on full delivery, walking nearly 12 miles a day. Now it gets to be 8:00 at night, and I’m still bouncing off the walls, full of energy. I feel that I owe everyone who was involved a massive thank you.”

FEATURES

The first occluder developed specially for patent foramen ovale (PFO) closure continues to leverage its role in the industry, with data conclusively demonstrating the excellent safety profile of the Amplatzer PFO Occluder.2 The Amplatzer PFO Occluder's design features are responsible for its success.

Often Imitated, Never Matched

†Effective closure

Amplatzer PFO Occluder demonstrated over 94 percent closure rate in clinical trial

*Only the 18mm size is not asymmetric

Minimizing Complexity in PFO Closure

UNIQUE
SELF-EXPANDING DISCS

Linked by a short-connecting waist, the discs align to the PFO with no need for an additional “locking” step
 

FULLY RECAPTURABLE, REPOSITIONABLE

Ensure optimal anatomical placement of the device for effective closure

 

Amplatzer PFO Occluder is recapturable and repositionable for better PFO closure

LOW-PROFILE
DELIVERY

8 F and 9 F introducer sheaths enable treatment of patients with smaller vasculature

Amplatzer PFO Occluder offers options for patients with smaller vasculature
Abbott Amplatzer Portfolio App helps physicians determine which structural intervention device to use

NEW VERSION AVAILABLE
GET THE AMPLATZER PORTFOLIO APP

The Amplatzer Portfolio App helps physicians determine which Amplatzer Structural Interventions device to use by suggesting applicable devices based on respective Instructions for Use.

App Store
Google Play

MAT-2010605 v3.0 | Item approved for Global OUS use only.

References
  1. 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;377:1022-1032. doi: 10.1056/NEJMoa1610057.
  3. 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.
  4. 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.
  5. Messé SR, Gronseth GS, Kent DM, et al. Practice advisory update summary: Patent foramen ovale and secondary stroke prevention: Report of the Guideline Subcommittee of the American Academy of Neurology. Neurology. 2020;94(20):876-885. doi:10.1212/WNL.0000000000009443
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