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CCN-2013-4

DEVICE PERFORMANCE • Successful delivery and deployment: 100% (120/120) • Repositioned successfully: 100% (31/31) • Retrieved successfully: 100% (6/6) • Valve malpositioning: 0% (120/120) • Valve migration: 0% (0/120) • Valve embolization: 0% (0/120) • Ectopic valve deployment: 0% (0/120) • TAV-in-TAV deployment: 0% (0/120) www.lotus-valve-system.eu All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for the use only in countries with applicable health authority product registrations. This material is not for use in the U.S. or Japan. Caution: The Lotus Valve is an investigational device limited by federal law to investigational use only and not available for sale in the U.S. © 2013 Boston Scientific Corporation or its affiliates. All rights reserved. SH-201606-AB OCT2013 REPRISE II is a prospective, single-arm, multicentre study designed to evaluate safety and performance of the Lotus™ Valve System for TAVI in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement. PARAVALVULAR AORTIC REGURGITATION • Impressively low paravalvular aortic regurgitation results, no cases of severe regurgitation. LotusLotusLotusLotusLotusLotusLotusLotusLotusTMTMTM Valve SystemValve SystemValve SystemValve SystemValve SystemValve SystemValve SystemValve SystemValve SystemValve SystemValve SystemValve SystemValve SystemTranscatheter Aortic Valve Implantation Device REPRISE II Results at 30 Days Follow-up REPRISE II Aortic Regurgitation Over Time (Core Lab Adjudicated Data) None Trace Mild Moderate Severe 78.4 15.5 5.25.25.25.2 12.5 20.5 20.5 43.8 2.72.72.72.72.7 Combined 15.2% Paravalvular 61.4 16.8 20.8 100 80 60 40 20 0 Baseline (N=112) 30 Days (N=103) 30 Days (N=103) PercentofEvaluableEchocardiograms(%) 1.01.01.01.01.01.01.01.01.01.01.0 Designed for Total Control • Its unique Adaptive Seal™ technology is designed to promote annular sealing and help prevent paravalvular leakage. • The Lotus™ Valve System is designed to be fully retrieved, redeployed, or repositioned including after full deployment and prior to release, for additional precision especially in challenging anatomies. • Its radiopaque marker and early valve operation provide the physician with confidence to position the valve accurately first time.

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