Ordering Information AMPLATZER PFO Occluder AMPLATZER PFO Occluder Structural Heart Therapy Model / Reorder Number Right Atrial Disc Diameter (mm) Left Atrial Disc Diameter (mm) 9-PFO-018 18 18 9-PFO-025 25 18 9-PFO-030 30 30 9-PFO-035 35 25 ™ 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(10 Suppl):S26-30. 5. Homma S, Sacco R. Patent Foramen Ovale and Stroke, Circ. 2005;112(7):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. ATRIAL FIBRILLATION CARDIAC RHYTHM MANAGEMENT CARDIOVASCULAR Global Headquarters One St. Jude Medical Drive St. Paul, Minnesota 55117 USA +1 651 756 2000 +1 651 756 3301 Fax Cardiovascular Division 177 East County Road B St. Paul, Minnesota 55117 USA +1 651 756 4470 +1 651 756 4466 Fax Amplatzer Products 5050 Nathan Lane North Plymouth, Minnesota 55442 USA +1 763 513 9227 +1 763 513 9226 Fax St. Jude Medical Coordination Center BVBA The Corporate Village Avenue Da Vincilaan 11 Box F1 B-1935 Zaventem Belgium +32 2 774 68 11 +32 2 772 83 84 Fax St. Jude Medical Japan Co., Ltd. Shiodome City Center 15F 1-5-2, Higashi-Shinbashi Minato-ku Tokyo 105 7115 Japan +81 3 6255 6370 +81 3 6255 6371 Fax St. Jude Medical (Hong Kong) Ltd. Suite 1608, 16/F Exchange Tower 33 Wang Chiu Road Kowloon Bay, Kowloon Hong Kong SAR +852 2996 7688 +852 2956 0622 Fax NEUROMODULATION St. Jude Medical Brasil Ltda. Rua Frei Caneca, 1380 7º ao 9º andares 01307-002 - São Paulo (SP) Brazil +55 11 5080 5400 +55 11 5080 5423 Fax (MM00151EN) SJMprofessional.com Product referenced is approved for CE Mark. Device not available in the U.S. Device depicted may not be available in all countries. Check with you St. Jude Medical representative for product availability in your country. Brief Summary: 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. AMPLATZER, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are trademarks and service marks of St. Jude Medical, Inc. and its related companies. ©2011 St. Jude Medical. All rights reserved. MM00151 (03.2) EN Intl 11/11 Success through Flexibility The AMPLATZER PFO Occluder has been designed to close all types of patent foramen ovale (PFO) with an easy-to-perform deployment procedure. SIMPLE AND CONFIDENT CLOSURE EXCELLENT CLINICAL RESULTS High Procedural Success1: Achieved through a simple delivery and procedural flexibility seen with all AMPLATZER occlusion systems High Closure Rates: With 96% of patients showing complete occlusion at three to six month follow-up1 Proven Performance: Through extensive clinical experience of over 60,000 devices implanted worldwide2 Simple and Confident Tr anscatheter PFO Closure Strong Safety Profile: Through low adverse event rates3 Rapid Endothelialization: Promoted through the Nitinol and polyester construction 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 The AMPLATZER PFO Occluder is a double-disc device comprised of Nitinol mesh and polyester fabric that can be easily recaptured and redeployed for precise placement. The discs are connected by a narrow waist designed to flex for an optimal fit. The radiopaque hubs and Nitinol mesh are engineered to provide good visualization under fluoroscopy. The AMPLATZER PFO Occluder is designed for secure apposition on each side of the defect for complete closure and tissue in-growth. 50 PFO AND CRYPTOGENIC STROKE P<0.001 Percent of Patients 40 P<0.001 30 20 10 0 <55 Yr Cryptogenic ≥55 Yr Known cause Prevalence of PFO is three times more common in cryptogenic stroke than stroke of known causes6 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 leftsided 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.6
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