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100092311_ASD.book Page 1 Monday, January 6, 2014 11:00 AM
™
Septal Occluder
bg: Септално устройство за
затваряне
Инструкции за употреба
bs: Septalni okluder
Uputstvo za upotrebu
cs: Septální okludér
Návod k použití
da: Septal okklusionsanordning
Brugsanvisning
de: Septum-Okkluder
Gebrauchsanweisung
el: Συσκευή απόφραξης
διαφράγματος
Οδηγίες χρήσης
es: Oclusor septal
Instrucciones de uso
et: Vaheseina sulgur
Kasutusjuhend
fi: Väliseinäaukon sulkija
Käyttöohjeet
fr: Dispositif d'occlusion septal
Mode d'emploi
Instructions for Use
hr: Septalni okluder
ro: Dispozitiv de închidere de
Upute za uporabu
hu: Szeptumtapasz
ru: окклюдер для перегородок
Használati utasítás
it: Occlusore settale
sk: Septálny okluzor
Istruzioni per l'uso
sl: Septalno zapiralo
ko: 중격 폐색기
사용 설명서
lt: Pertvaros okliuderis
sq: Okludues septal
Naudojimo instrukcija
lv: Starpsienas Nosprostotājs
sr: Septalni okluder
Lietošanas instrukcija
nl: Septale occluder
sv: Anordning för slutning
Gebruiksaanwijzing
no: Septal lukkeanordning
tr: Septal Oklüder
Bruksanvisning
pl: Korek do zamykania
zh: 房间隔缺损封堵器
ubytków przegrody
Instrukcja użytkowania
pt: Dispositivo de oclusão
ar:
septal
Instruções de Utilização
sept
Instrucţiuni pentru utilizare
Инструкции по применению
ventrikulárnych septálnych
defektov
Návod na použitie
Navodila za uporabo
Udhëzime për përdorim
Uputstvo za upotrebu
av septum
Bruksanvisning
Kullanma Talimatı
使用说明
ﺗﻌﻠﻳﻣﺎﺕ ﺍﻻﺳﺗﺧﺩﺍﻡ
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Summary of Contents for St. Jude Medical Amplatzer
- Page 1 100092311_ASD.book Page 1 Monday, January 6, 2014 11:00 AM ™ Septal Occluder Instructions for Use bg: Септално устройство за hr: Septalni okluder ro: Dispozitiv de închidere de затваряне Upute za uporabu sept Инструкции за употреба Instrucţiuni pentru utilizare bs: Septalni okluder hu: Szeptumtapasz ru: окклюдер...
- Page 2 100092311_ASD.book Page 2 Monday, January 6, 2014 11:00 AM Does not contain natural rubber latex components / Не съдържа компоненти от естествен гумен латекс / Ne sadrži komponente prirodnog gumenog lateksa / Neobsahuje složky přírodního latexu / Indeholder ikke komponenter af naturlig gummilatex / Enthält keine Naturlatex-Komponenten / ∆εν...
- Page 3 100092311_ASD.book Page 3 Monday, January 6, 2014 11:00 AM Recommended delivery sheath dimensions / Препоръчителни размери на маншона за въвеждане / Preporučene dimenzije uvodnice / Doporučené rozměry zaváděcího pouzdra / Anbefalede dimensioner for indføringshylster / Empfohlene Maße der Einführschleuse / Συνιστώμενες διαστάσεις θηκαριού προώθησης...
- Page 4 100092311_ASD.book Page 4 Monday, January 6, 2014 11:00 AM Federal law (USA) restricts this device to sale by or on the order of a physician (or properly licensed practitioner). / Според федералното законодателство (на САЩ) продажбата на това устройство може да стане само по поръчка на лекар...
- Page 5 100092311_ASD.book Page 1 Monday, January 6, 2014 11:00 AM en: Instructions for Use ...................1 bg: Инструкции за употреба................15 bs: Uputstvo za upotrebu ................23 cs: Návod k použití ..................30 da: Brugsanvisning..................37 de: Gebrauchsanweisung................44 el: Οδηγίες χρήσης ..................52 es: Instrucciones de uso................60 et: Kasutusjuhend..................67 fi: Käyttöohjeet....................74 fr : Mode d’emploi..................81...
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Page 6: Device Description
Radiopaque marker bands at each end of the device provide visualization under fluoroscopy. The AMPLATZER™ 45° Delivery System was designed to facilitate attachment, loading, delivery, and deployment of the AMPLATZER™ Occluders and is composed of: •... - Page 7 • The use of this device has not been studied in patients with patent foramen ovale. • Use standard interventional cardiovascular catheterization techniques when using AMPLATZER™ products. • The physician should exercise clinical judgment in situations that involve the use of...
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Page 8: Adverse Events
• MR Conditional Through non-clinical testing, AMPLATZER™ devices have been shown to be MR Conditional. A patient with an implanted AMPLATZER™ device can be scanned safely immediately after placement of the device under the following conditions: - Static magnetic field of 3 T or less... -
Page 9: Potential Adverse Events
100092311_ASD.book Page 4 Monday, January 6, 2014 11:00 AM Potential Adverse Events Potential adverse events that may occur during or after a procedure placing this device include, but are not limited to air embolus, allergic reaction, apnea, arrhythmia, arteriovenous fistulae, bleeding, brachial plexus injury, cardiac perforation, cardiac tamponade, death, device embolization/migration, dissection, endocarditis, erosion, fever, foreign material embolic event, headache/migraine, heart block, hematoma/pseudoaneurysm including blood loss requiring... -
Page 10: Clinical Summary
100092311_ASD.book Page 5 Monday, January 6, 2014 11:00 AM Clinical Summary The AMPLATZER™ Septal Occluder was evaluated in a multi-center, non-randomized, pivotal study comparing the device to surgical closure of atrial septal defects (ASDs); 423 patients received 433 devices with a total device exposure of 911.5 years. Individual patient exposure to the device averaged 25.6 months (ranging from 0 to 38.9). -
Page 11: Patients Studied
0.181 Clinical Studies The AMPLATZER™ Septal Occluder was evaluated in a multi-center, non-randomized controlled study to compare the clinical performance of the device for ASD closure with that documented for the ASD surgical repair procedure. Additionally, the device was studied in patients with uncommon conditions wherein transcatheter closure with the device may also be beneficial (Registry Group). - Page 12 6 months. Patients underwent physical examination that included heart murmur classification, electrocardiogram, chest x-ray, and 2D color Doppler transthoracic echocardiogram (TTE). Table 3. Patient Baseline Demographics AMPLATZER™ Variable Surgical Control Patients p-value Patients Mean ±...
- Page 13 100092311_ASD.book Page 8 Monday, January 6, 2014 11:00 AM Registry Group – Fenestrated Fontan Table 4. Pre-closure – Fenestrated Fontan Mean ± s.d.(N) 7.8 ± 6.9 (48) Age (years) [range] [1.6, 44.9] Female 29/48 (60.4%) Gender Male Mean ± s.d.(N) 114.5 ±...
- Page 14 [-0.048, +0.026] a. Unit of analysis = Patient. Although 10 patients had 2 defects each treated with an AMPLATZER™ Septal Occluder, all patients with multiple AMPLATZER™ implants were successfully treated. Technical Success: Successful deployment of the device, or the successful completion of the surgical procedure.
- Page 15 100092311_ASD.book Page 10 Monday, January 6, 2014 11:00 AM Table 6. Principal Effectiveness and Safety Results – Patient Age Less Than 20 Years AMPLATZER™ Surgical Control 90% Confidence Patients Patients Interval Technical Success 315/328 (96.0%) 149/149 (100%) (-0.086, -0.005) Procedure Success 306/315 (97.1%)
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Page 16: Directions For Use
100092311_ASD.book Page 11 Monday, January 6, 2014 11:00 AM Directions for Use Materials recommended for use with the device • The AMPLATZER™ 45° Delivery System or the AMPLATZER™ TorqVue™ 45° Delivery System (both sold separately) is recommended for use with the AMPLATZER™ Septal Occluder. - Page 17 100092311_ASD.book Page 12 Monday, January 6, 2014 11:00 AM 9. Select the appropriate delivery system for the device size (see Table T1). 10. Prepare the delivery system for use according to the manufacturer’s instructions for use. Insert the dilator into the delivery sheath and tighten the rotating luer. Advance the dilator and delivery sheath over the guidewire, through the defect, and into the left upper pulmonary vein.
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Page 18: Warranty
See the Terms and Conditions of Sale for further information. For Australia Only This warranty is given by St. Jude Medical (SJM). To make inquiries regarding this warranty, use the contact information for either the manufacturer or Australian Sponsor located on the back cover. - Page 19 EXCEPT FOR MANDATORY TERMS IMPLIED BY LAW, MANDATORY CONSUMER GUARAN- TEES, OR AS EXPRESSLY PROVIDED IN THIS WARRANTY, ST. JUDE MEDICAL DISCLAIMS ANY REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED. See the...
- Page 20 100092311_ASD.book Page 230 Monday, January 6, 2014 11:00 AM Device and delivery system dimensions (sold separately) / Размери на устройството и системата за въвеждане (продават се отделно) / Dimenzije uređaja i uvodnog sistema (prodaju se zasebno) / Rozměry zařízení a zaváděcího systému (prodává se samostatně) / Anoordningens og indføringssystemets dimensioner (sælges separat) / Abmessungen des Produkts und des Einführsystems (separat erhältlich) / ∆ιαστάσεις...
- Page 21 100092311_ASD.book Page 231 Monday, January 6, 2014 11:00 AM (inch) (inch) 2.69 3.45 9-ITV08F45/60 (0.106) (0.136) 9-ASD-018 2.69 3.45 9-ITV08F45/80 (0.106) (0.136) 2.71 3.38 9-DEL-8F-45/60 (0.107) (0.133) 9-ASD-019 2.71 3.38 9-DEL-8F-45/80 (0.107) (0.133) 3.00 3.81 9-ITV09F45/80 (0.118) (0.150) 2.71 3.38 9-ASD-020 9-DEL-8F-45/60 (0.107)
- Page 22 100092311_ASD.book Page 232 Monday, January 6, 2014 11:00 AM Not available in all markets. / Не се предлагат на всички пазари. / Nije dostupno na svim tržištima. / Není k dispozici na všech trzích. / Fås ikke på alle markeder. / Nicht in allen Märkten erhältlich.
- Page 23 100092311_ASD.book Page 232 Monday, January 6, 2014 11:00 AM...
- Page 24 EE.UU. y/u otros países, se encuentran enumerados en www.amplatzer.com/patents. Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and services marks of St. Jude Medical, Inc.
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