K. Mathias Clinical and Interventional Angiology AK St. Georg Hamburg / Germany Results of the German Ovation Trial.

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Presentation transcript:

K. Mathias Clinical and Interventional Angiology AK St. Georg Hamburg / Germany Results of the German Ovation Trial

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

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

 FIXATION  SEAL Solution for 2 Problems  PROFILE... and for percutaneous access

Fixation and Sealing are 2 Seperate Tasks ANCHORS SEALING COLLAR SEALING RING SECONDARY SEALING RING FIXATION SEALING ZONE

Profile Fr 14 Fr 40% Reduction versus other available systems

Main Body Delivery System

Iliac Limbs

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

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

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

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

First European Patient March 16, 2010 by Thomas Nolte, Herz- und Gefäßzentrums Bad Bevensen, Pre-Procedure ImageAfter EVAR30 Day Post

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.