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
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%
Relative Risk Reduction for any Recurrent Ischemic Stroke: 45%
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.
Learn more about Amplatzer™ PFO Occluder by visiting the Abbott Structural Heart website.
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
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.
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.
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.
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.
Data on file at Abbott.
*On commonly used sizes (25 mm and 35 mm devices)
MAT-2010368 v1.0
DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?
CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.
[prod, crx3, samplecontent, publish, crx3tar]
DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?
CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.
Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.
Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.