AMPLATZER Amulet Left Atrial Appendage Occluder
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1 AMPLATZER Amulet Left Atrial Appendage Occluder
2 EXPECT THE BEST OF ALL WORLDS FROM YOUR LEFT ATRIAL APPENDAGE OCCLUDER: Ease of use, the broadest range of sizes and a design allowing for a complete ostial seal. Appendage anatomies come in all shapes and sizes and your stroke prevention device should too. The AMPLATZER Amulet left atrial appendage occluder is built on the proven AMPLATZER technology, and offers a conformable disc and lobe designed for complete occlusion of the left atrial appendage, the broadest size range on the market today and enhanced ease-of-use.
3 Complete closure is the goal. The AMPLATZER Amulet device features a unique design intended to completely seal the left atrial appendage at the orifice. Flexible nitinol braid allows for conformability to different types of appendage anatomy. Complete range of sizes to seal left atrial appendages with landing zone diameters from 11 to 31 mm. 1 Proximal device positioning optimizes placement regardless of distal anatomy or multiple distal lobes. 1 Waist Disc Lobe Stabilizing Wires
4 Experience ease-of-use and precise device positioning. Insist on an LAA occlusion system that gives you: Simplified preparation and de-airing procedure Single-piece cable design for ease of delivery and better control A longer waist for more flexible placement within the LAA The ability to be fully repositioned and recaptured for optimal placement AMPLATZER technology makes the choice clear. The AMPLATZER Amulet device is an alternative therapy for reducing the risk of stroke in your patients with atrial fibrillation 2. It leverages the proven technology of the AMPLATZER Cardiac Plug, which has shown: 98% occlusion rate with a complete seal of the LAA at follow-up 3 97% demonstrated technical success 3 63% stroke risk reduction, versus predicted stroke rate in high-risk patient populations 3 60% bleeding risk reduction, versus predicted risk based on HAS-BLED scores 3
5 Streamlined procedure keeps you in control. 3 1 Orifice Landing Zone Depth Measure the left atrial appendage orifice, landing zone and depth 3 2 Deploy the lobe of the AMPLATZER Amulet occluder in the landing zone of the LAA 3 3 Deploy the disc of the AMPLATZER Amulet device to fully cover the LAA ostium 3 4 Release the AMPLATZER Amulet device from the delivery cable
6 Ordering Information Description Reorder Number Size AMPLATZER Amulet Left Atrial Appendage Occluder 9-ACP mm 9-ACP ACP ACP ACP ACP ACP ACP mm 20 mm 22 mm 25 mm 28 mm 31 mm 34 mm Accessories AMPLATZER TorqVue 45 x 45 Delivery Sheath 9-TV45x45-12F F AMPLATZER TorqVue 45 x 45 Delivery Sheath 9-TV45x45-14F F AMPLATZER Guidewire 9-GW " 1. AMPLATZER Amulet Instructions for Use 2. National Institute for Health and Care Excellence. Atrial fibrillation: the management of atrial fibrillation - NICE clinical guideline 180 (August 2014). 3. Tzikas, et al. Multicenter Experience with the Amplatzer Cardiac Plug (ACP). Presented at the TCT Conference in San Francisco, CA on October 27, Slides available online at CAUTION: Device not available in the United States. Product referenced is approved for CE Mark. Device depicted may not be available in all countries. Check with your St. Jude Medical representative for product availability in your country. Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. 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 service marks of St. Jude Medical, Inc. and its related companies St. Jude Medical, Inc. All Rights Reserved. St. Jude Medical Inc. Global Headquarters One St. Jude Medical Drive St. Paul, Minnesota USA T F St. Jude Medical S.C., Inc. Americas Division 6300 Bee Cave Road Bldg. Two, Suite 100 Austin, TX USA T F SJM Coordination Center BVBA The Corporate Village Da Vincilaan 11-Box F1 B-1935 Zaventem, Belgium T F St. Jude Medical Brasil Ltda. Rua Itapeva, 538 5º ao 8º andares São Paulo SP Brazil T F St. Jude Medical (Hong Kong) Ltd. Suite 1608, 16/F Exchange Tower 33 Wang Chiu Road Kowloon Bay, Kowloon Hong Kong SAR T F St. Jude Medical Japan Co., Ltd. Shiodome City Center 15F Higashi Shinbashi, Minato-ku Tokyo Japan T F St. Jude Medical Australia Pty, Ltd. 17 Orion Road Lane Cove, NSW 2066 Australia T F SJMprofessional.com SJM-AMU (10/14) This document is for international use only.
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