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AMPLATZER™ PFO Occluder

This device is commercially available for use in select international markets.

Simple and Confident Transcatheter PFO Closure

The AMPLATZER PFO Occluder is a double-disc device comprised of Nitinol mesh and polyester fabric. It has been designed to close all types of PFOs with an easy-to-perform deployment procedure.

 

This product is not approved by the United States FDA.

AMPLATZER™ PFO Occluder
Overview

Simple and Confident Closure

  • High Procedural Success1: Achieved through a simple delivery and procedural flexibility seen with all AMPLATZER occlusion systems
  • Precise Placement: With the ability to be easily recaptured and repositioned if improperly deployed
  • Proven Performance: Through extensive clinical experience of over 60,000 devices implanted worldwide2

Engineered to Fit all PFO Anatomies

  • Optimal Fit: Achieved with a flexible, narrow waist designed to keep each disc well-apposed to the septal wall
  • Broad Treatment Range: Accomplished by offering multiple device sizes to select the best fit for unique patient anatomy.

Excellent Clinical Results

  • High Closure Rates: With 96% of patients showing complete occlusion at three to six month follow-up1
  • Promotes Endothelialization: Through the Nitinol and polyester construction

Prevalence of PFO

Prevalence of PFO

Patent foramen ovale (PFO) is the most common structural heart defect with a prevalence of nearly 25% in the general population.4 In a portion of these adults, by maintaining a direct communication between the right and left-sided circulation, PFO can serve as a conduit for paradoxical embolization.5 Existing data show there is a strong association between the presence of patent foramen ovale and cryptogenic stroke independent of age and that paradoxical embolism is a cause of stroke (Figure 1).6 Percutaneous closure aims to reduce the risk of recurrent thromboembolic events with less procedural morbidity and faster recovery time than that associated with open heart surgery.

Prevalence of PFO Graph

Figure 1: Prevalence of PFO is three times more common in cryptogenic stroke than stroke of known cause.6 


References

1 Chatterjee, T, Petzsch M, Ince H, et al. Interventional closure with Amplatzer PFO occluder of patent foramen ovale in patients with paradoxical cerebral embolism. J Interv Cardiol. 2005;18(3):173-9.

2 Data on File at St Jude Medical, number of implants as of March, 2011.

3 Amin Z, Hijazi Z, Bass J, et al. PFO closure complications from the AGA registry. Catheter Cardiovasc Interv. 2008;72(1):74-9.

4 Kent D, Thaler, D. Is Patent Foramen Ovale a Modifiable Risk Factor for Stroke Recurrence? Stroke. 2010;41:S26-30.

5 Homma S, Sacco R. Patent Foramen Ovale and Stroke. Circ. 2005;112:1063-72.

6 Handke M, Harloff A, Olschewski M, et al. Patent Foramen Ovale and Cryptogenic Stroke in Older Patients. N Engl J Med. 2007;357(22):2262-8.

Tech Specs

AMPLATZER™ PFO Occluder

Ordering Information   View Catalog   

Contents: 1 occluder

Reorder Number Right Atrial Disc Diameter (mm) Left Atrial Disc Diameter (mm) Min. Recommended Sheath Size (AMPLATZER™ TorqVue™ Delivery System)
9-PFO-018 18 18 8 F, 45° Curve
9-PFO-025 25 18 8 F, 45° Curve
9-PFO-030 30 30 8 F, 45° Curve
9-PFO-035 35 25 9 F, 45° Curve

Evidence

RESPECT Clinical Trial

The RESPECT clinical trial was initiated to assess patent foramen ovale (PFO) closure with the AMPLATZER™ PFO Occluder plus medical management compared to medical management alone in the prevention of recurrent cryptogenic strokes in patients with PFO. The RESPECT clinical trial announced in early 2012 that a study stopping rule had been met and patient enrollment was closed. At that time, 980 patients had been enrolled and more than 2,300 years of patient data were collected over the course of the 8+ year clinical trial.

ATTENTION RESPECT INVESTIGATORS: Subject follow up in the RESPECT Clinical Trial must continue as per protocol.

AMPLATZER™ PFO Occluder 

Indications, Safety & Warnings
Print

Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Product referenced is approved for CE Mark. Not available for sale in the U.S. Device depicted may not be available in all countries.

Last Updated: 19 April 2013