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