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K. Mathias Clinical and Interventional Angiology AK St. Georg Hamburg / Germany Results of the German Ovation Trial
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German Trial Sites SITELOCATIONSITE PISPECIALTY Herz-und Gefässzentrum Bad BevensenNolte Vascular Surgeon Uni. Klinik KölnKölnBrunkwall Vascular Surgeon Augusta-KrankenhausDüsseldorfKolvenbach Vascular Surgeon Universitäres Herz und Gefäßzentrum HamburgKrankenberg Interventional Cardiologist Klinikum DortmundDortmundMathias Interventional Radiologist Universitätsklinikum Rostock RostockNienaber Interventional Cardiologist Park KrankenhausLeipzigScheinert Interventional Cardiologist Sankt KatharinenFrankfurtSievert Interventional Cardiologist St. Franziskus-HospitalMünsterTorsello Vascular Surgeon
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TRI-MODULAR DESIGN 14-15F OD PTFE MAIN BODY SUPRARENAL STENT WITH ANCHORS FOR FIXATION 13-15F OD CONFORMABLE ILIAC LIMBS INFLATABLE RINGS FOR OPTIMAL SEAL LOW-VISCOSITY, RADIOPAQUE, FILL POLYMER The Product: Ovation™ *TriVascular Comp., California
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FIXATION SEAL Solution for 2 Problems PROFILE... and for percutaneous access
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Fixation and Sealing are 2 Seperate Tasks ANCHORS SEALING COLLAR SEALING RING SECONDARY SEALING RING FIXATION SEALING ZONE
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Profile 18-24 Fr 14 Fr 40% Reduction versus other available systems
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Main Body Delivery System
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Iliac Limbs
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Fill Polymer / Autoinjector AUTOINJECTOR Provides reliable, pressure-controlled filling Low-pressure (15 psi, 1 atm) Passive – requires no physician’s attention after connection FILL POLYMER In-situ gelling polymer Stable, biocompatible, and soluble Supplied in ready-to-mix kit 15 mix strokes
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German Clinical Ovation TM Trial Objective: 2-year safety and performance Primary Endpoint: SAE within 30 days of the procedure Secondary Endpoints: Treatment success defined as: Deployment Freedom From: Type I, III & IV endoleak, migration, AAA enlargement, rupture, and conversion Follow-up: 1 month, 6 months, 2 years and annually to 5 years
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Inclusion & Exclusion Criteria AAA ≥ 5.0 cm in diameter or ≤ 5.0 cm in diameter if: Ø increased ≥ 5 mm in 6 months Ø is 1.5 times normal aortic diameter Proximal neck: ≥ 7 mm in length 16 to 30 mm in diameter (ID) ≤ 45° angle (neck < 10 mm) ≤ 60° angle (neck ≥ 10 mm) Distal Iliac landing zone of: ≥ 10 mm in length 8 to 20 mm diameter (ID) Overall length from renal to hypogastric artery ≥ 130 mm Adequate iliac/femoral access compatible with the delivery systems
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CE Mark Clinical Experience 0-30 Days SAFETY Serious Adverse Events 1 9.5% (2/21) Chronic Anemia (secondary to myelodysplasia) 4.76% (1/21) Hypertensive Crisis 4.76% (1/21) PERFORMANCE Technical Success 100% (21/21) Freedom from Type I, III, and IV Endoleak 100% (21/21) Freedom from Aneurysm Rupture 100% (21/21) Freedom from Conversion to Open Surgical Repair 100% (21/21) Freedom from Secondary Interventions 100% (21/21) Freedom from Mortality 100% (21/21) Composite Success Rate100% (21/21) 1 None of the SAEs were device related
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First European Patient March 16, 2010 by Thomas Nolte, Herz- und Gefäßzentrums Bad Bevensen, Pre-Procedure ImageAfter EVAR30 Day Post
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Summary The Ovation Abdominal System is a novel technology that optimizes the two most important requirements for EVAR, fixation and seal. The clinical trail has yielded excellent short-term results across a broad cohort of patients. The 14F OD system offers the lowest profile of any commercially available device, and is designed to expand the patient population suitable for endovascular aortic repair (EVAR) by addressing a wider range of diseased anatomies.
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