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CARDIOVASCULAR
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BACK

INDUSTRY-LEADING DEVICE. DESIGNED SPECIFICALLY FOR PFO CLOSURE.

A Landmark Device. And a Turning Point for PFO Closure.

The Amplatzer™ PFO Occluder set the standard, pioneering treatment with a device developed specifically for PFO closure. It’s the leading PFO closure device to date, with over 130,000 devices implanted worldwide.4

Amplatzer PFO Occluder

Four 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.1-4 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 trial1

  • 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 at 6 months
  • Only trial to include patients on anticoagulation therapy

Comments from RESPECT Trial Principal Investigator

Jeffrey Saver, MD discusses the data supporting the benefits of PFO closure.

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 alone in preventing recurrent stroke.1

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

Relative Risk Reduction for Recurrent Stroke of Unknown Cause: 62%

Amplatzer PFO relative risk reduction for recurrent cryptogenic stroke

Relative Risk Reduction for any Recurrent Ischemic Stroke: 45%

Amplatzer PFO relative risk reduction for any recurrent ishemic stroke

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% Device Erosion
  • 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 patients who've had an ischemic stroke, may consider these factors in treatment planning:

  • Is there a known cause for the stroke?
    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 a PFO?
    Determine the likelihood of paradoxical embolism

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

Leadership in PFO Closure Treatment

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

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.

Amplatzer PFO Design

Learn more about Amplatzer™ PFO Occluder by visiting the Abbott Structural Heart website.

Ordering Information

SIZING AND DEVICE SELECTION
Amplatzer™ PFO Occluder
Model/Reorder Number Right Atrial Disc Diameter
A		 Left Atrial Disc Diameter
B		 Minimum Recommended Sheath Size
9-PFO-018 18 mm 18 mm 8 F; 45° curve
9-PFO-025 25 mm 18 mm 8 F; 45° curve
9-PFO-030 30 mm 30 mm 8 F; 45° curve
9-PFO-035 35 mm 25 mm 9 F; 45° curve
Amplatzer PFO
DELIVERY SYSTEM
Amplatzer Trevisio™ Intravascular Delivery System
Model/Reorder Number Sheath Size Tip Angle Sheath Inner Diameter Sheath Outer Diameter Usable Length
9-ATV08F45/80 8 F 45° 2.69 mm/0.11 inch 3.45 mm/0.14 inch 80 cm
9-ATV09F45/80 9 F 45° 3.00 mm/0.12 inch 3.81 mm/0.15 inch 80 cm
Amplatzer TorqVue® 45° Delivery System
9-ITV08F45/80 8 F 45° 2.69 mm/0.11 inch 3.45 mm/0.14 inch 80 cm
9-ITV09F45/80 9 F 45° 3.00 mm/0.12 inch 3.81 mm/0.15 inch 80 cm
ANCILLARY PRODUCTS
Amplatzer Guidewire
Model/Reorder Number Diameter Body Tip Description Usable Length
9-GW-002 0.035 inch Super Stiff 1.55 mm, Modified J-tip 260 cm
Amplatzer TorqVue® Exchange Systems
Ordering Information - Contents: 1 each delivery sheath, dilator, exchange wire, hemostasis valve, loader, and plastic vise
Model/Reorder Number Sheath Size Tip Angle Sheath Inner Diameter Sheath Outer Diameter Usable Length
9-EITV09F45/80 9 F 45° 3.00 mm/0.12 inch 3.81 mm/0.15 inch 80 cm
9-EITV12F45/80 12 F 45° 3.99 mm/0.16 inch 4.80 mm/0.19 inch 80 cm
DEVICE SIZING GUIDELINES
Shortest Distance from Defect to Aortic Root or Distance from Defect to Superior Vena Cava Orifice (mm) Suggested Amplatzer PFO Occluder size (mm)
Greater than or equal to 17.5 35
15.0-17.4 30
12.5-14.9 25
9-12.4 18
less than 9 Do not implant device

References

  1. 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. 
  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, 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.
  4. Lee, Pil Hyung et al. “Cryptogenic Stroke and High-Risk Patent Foramen Ovale: The DEFENSE-PFO Trial.” Journal of the American College of Cardiology vol. 71,20 (2018): 2335-2342. doi:10.1016/j.jacc.2018.02.046.
  5. Data on file at Abbott.

         

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

 

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© 2016 Abbott. All Rights Reserved. Please read the Legal Notice for further details.

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