AMPLATZER PFO Occluder | PFO Closure Device
CARDIOVASCULAR
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INDUSTRY-LEADING DEVICE. DESIGNED SPECIFICALLY FOR PFO CLOSURE

Three published clinical trials provide conclusive evidence of the superiority of Patent Foramen Ovale (PFO) closure in reducing the risk of recurrent stroke compared with medical management.1-3 The RESPECT trial, the largest trial with the most extensive patient follow-up, demonstrated an excellent safety profile while significantly reducing the risk of recurrent stroke:1

Highlights from the RESPECT trial:1

  • The most extensive patient follow-up with 5,810 patient years of data
  • Zero device erosions, thrombus, or embolization events
  • 94.2% effective closure rates after 6 months
  • Only trial to include patients on anticoagulation therapy

A LANDMARK DEVICE. AND A TURNING POINT FOR PFO CLOSURE.

The Amplatzer PFO Occluder set the standard and pioneered treatment with a device developed specifically for PFO closure. And it’s the leading PFO closure device to date, with over 100,000 devices implanted worldwide.4

COMMENTS FROM THE RESPECT TRIAL PRINCIPAL INVESTIGATOR

References

1. Saver JL, 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. 
2. 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.
3. Mas J-L, 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.
4. Data on file at Abbott.

LEADERSHIP IN PFO CLOSURE TREATMENT

The Amplatzer PFO Occluder’s unique design is a primary reason for its safety and efficacy.

features of Amplatzer PFO closure device

In addition, the occluder’s capability to be fully recaptured and fully repositioned allows physicians to confirm proper placement prior to final release of the device.

References

1. Saver JL, 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. 
2. 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.
3. Mas J-L, 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.
4. Data on file at Abbott.

RESPECT TRIAL: A TURNING POINT IN PFO CLOSURE

The RESPECT trial is notable for demonstrating that the Amplatzer PFO Occluder is more beneficial than medical therapy in preventing recurrent stroke.1

The findings also revealed a reduction in the risk of recurrent cryptogenic stroke with the use of the Amplatzer PFO Occluder:1

 

RELATIVE RISK REDUCTION FOR RECURRENT CRYPTOGENIC STROKE 62%

62% reduced relative risk

 

RELATIVE RISK REDUCTION FOR ANY RECURRENT ISCHEMIC STROKE 45%

45% reduced relative risk

 

The trial analysis reveals that the device reduced recurrent ischemic stroke by eliminating a conduit through which venous source emboli can travel to the brain.

LOW RATE OF SERIOUS ADVERSE EVENTS

RESPECT data further revealed low rates of serious adverse events:1

  • 0% Device Embolization
  • 0% Aortic Erosion/Dissection
  • 0% Device Thrombus

EXCELLENT PROCEDURAL RESULTS

In the RESPECT Trial, the device demonstrated high rates of technical and procedural success and achieved excellent effective closure with highly stringent criteria.

99.1% Technical Success

96.1% Procedural Success

94.2% Effective closure at 6 months (n ≥ 9 bubbles)

PRIORITIZING PREVENTION

Referring physicians and particularly neurologists, who provide the primary point of care for recurrent stroke prevention, may consider these factors in treatment planning.

  • Is the stroke cryptogenic?
    Rule out known causes
  • Is the patient a good candidate for alternative therapy?
    Consider the patient’s age and medical history
  • Is there a possibility of PFO?
    Determine the likelihood of paradoxical embolism

A cardiologist can then determine whether a PFO is present and can help define treatment options.

References

1. Saver JL, 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. 
2. 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.
3. Mas J-L, 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.

AMPLATZER PFO OCCLUDER AND RELATED PRODUCTS

amplatzer

 

References

1. Saver JL, 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. 
2. 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.
3. Mas J-L, 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.

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