14F OD Ovation Abdominal Stent Graft System
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1 14F OD Ovation Abdominal Stent Graft System 2 Year Results from the European Study Dierk Scheinert, MD Center for Vascular Medicine Angiology and Vascular Surgery Park Hospital Leipzig, Germany
2 Disclosure Within the last 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organizations listed below. Advisory Board /Consultant: Abbott, Angioslide, Atheromed, Biotronik, Boston Scientific, Cook Medical, Cordis, Covidien, CR Bard, Gardia Medical, Medtronic, TriReme Medical, Trivascular, Upstream Peripheral Technologies Stockholder/ Consultant: IDEV Technologies
3 Why Another EVAR Device?
4 Problems with Commonly Used Stent Grafts Narrow and tortuous iliac arteries preclude access to treatment area Hostile necks, thrombus and calcium prevent an effective seal
5 Ovation Abdominal Stent Graft Suprarenal nitinol stent with anchors for fixation 14F OD Aortic Body filled with a lowviscosity, radiopaque, fill polymer Tri-modular design Inflatable rings for optimal seal 13-14F OD conformable iliac limbs
6 TriVascular Abdominal Study A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System Primary Safety Endpoint: MAE within 30 days of the procedure, as determined by Clinical Events Committee Primary Performance Endpoint: Treatment success defined as: Successful Delivery and Deployment Freedom from rupture, and conversion to open surgical repair Freedom from Type I and III endoleaks, migration, enlargement, as determined by Core Lab Follow-up: 1 month, 6 month and annual to 5 years
7 Selected Inclusion 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 hypo 130 mm Adequate iliac/femoral access compatible with the required delivery systems
8 EU Enrolling Institutions SITE LOCATION SITE PI SUBJECTS Herz-und Gefässzentrum Bad Bevensen Nolte 12 Uni. Klinik Köln Köln Brunkwall 1 Medical Care Center Prof Mathey Prof Schofer Hamburg Krankenberg 6 Klinikum Dortmund Dortmund Mathias 2 Park Krankenhaus Leipzig Scheinert 2 Sankt Katharinen Frankfurt Sievert 5 St. Franziskus-Hospital Münster Torsello 2
9 Patient Demographics PATIENT PROFILE Age Mean, (SD) 71.9, (6.5) Gender Male 90.0% CO-MORBIDITIES Coronary Artery Disease 33.3% (10/30) Valvular Heart Disease 10.0% (3/30) Previous MI 16.7% (5/30) Hypertension 73.3% (22/30) Hyperlipidimia 46.7% (14/30) PVD 13.3% (4/30) Smoker 60.0% (18/30) Other Significant Medical Condition 66.7% (20/30)
10 Anatomical Characteristics Aortic Neck Length (n=30) 23% of treated aortic necks shorter than 15mm % were < 10mm in length <10 mm mm mm mm 25 mm Minimum Access Vessel Diameter (n=30) 47% of patients treated had an access vessel < 7mm in diameter Minimum diameter access vessel treated = 3.2mm mm 6.1-7mm mm >8 mm
11 Procedure Characteristics PROCEDURE DATA Total Procedure Time (min) Mean +/- (SD) 107 (50) Device Time (min) Mean +/- (SD) 47 (34) Procedural Blood Loss (ml) Mean +/- (SD) 142 (137) ANESTHESIA* General Anesthesia 53% 16/30 Regional Anesthesia 7% 2/30 Local or Conscious Sedation 50% 15/30 PRIMARY VESSEL ACCESS Percutaneous 57% Cut Down 47% Cut Down & Percutaneous 3% * Some patients received more than one type of anesthesia.
12 Primary Safety Based on Clinical Events Committee (CEC) adjudicated data SAFETY 0-30 Days Days Major Adverse Events 0% (0) 10% (3) Device Related Major Adverse Events 0% 0% All Cause Mortality 0% 6.6% (2) MAEs at 1 year: 1 subject with myocardial infarction 1 subject with death due to suspected TAA rupture 1 subject with GI hemorrhage and death
13 Performance Based on Core Lab Data (M2S results) PERFORMANCE 30 Day 1 Year 2 Year Technical Success 100% N/A N/A Freedom from Type I and III Endoleaks 100% 100% 100% Freedom from Migration 100% 100% 100% Freedom from Rupture 100% 100% 100% Freedom from Conversion to Open Repair 100% 100% 100% ANEURYSM ASSESSMENT 30 Day 1 Year 2 Year Enlargement >5mm Baseline 4% (1/27) 4% (1/25) No change Baseline 70.4% (19/27) 60%(15/25) Reduction >5mm Baseline 26%(7/27) 36% (9/25) One aneurysm enlargement >5mm was observed at 6 months, persisting at 1 year follow up (stable) and with regression to baseline diameter at 2 years follow up. Investigator reported a type II endoleak in this patient. One aneurysm enlargement >5mm was observed at 2 year for one subject. Investigator reported a type II endoleak in this patient. Patient has undergone reintervention and with stable outcome as a result.
14 Patients (%) Sac Regression at 2 years 100,0 90,0 80,0 70,0 60,0 50,0 40,0 30,0 20,0 10,0 0,0 89,0 70,0 60,0 4,0 4,0 4,0 7,0 6 Month 1 Year 2 years 36,0 26,0 Enlargement >5 mm No Change Reduction >5mm Core Lab reported one aneurysm enlargement >5mm at 6 months, persisting at 1 year follow up (stable) and with regression to baseline diameter at 2 years follow up. Investigator reported a type II endoleak in this patient. Core Lab reported one aneurysm enlargement >5mm at 2 year for one subject. Investigator reported a type II endoleak in this patient.
15 Expanding EVAR Safely
16 Case Example Access & Seal in Challenging Anatomy Anatomical Measurements: Neck Length: 9 mm Aortic Diameter: 26 mm Juxtarenal Angulation: 15 O AAA Diameter: 7.3 cm Access Vessel Diameter: 7 mm (L) / 7 mm(r) Technical Aspects: Kinking Access Vessels Infrarenal Angulation Devices Used: Aortic Body: 34 mm Right Iliac Limb: 18 x 140 mm Left Iliac Limb: 18 x 140 mm Image courtesy of Dr T Nolte, Bad Bevesen
17 Hostile Neck - Difficult Access:
18 12 m f/u:
19 Access & Seal in Challenging Anatomy 2 yr Follow Up Pre-Op 2 year f/u Maximum Sac Diameter Baseline (30d) = 63.3mm 2 yr follow-up = 55.3mm 2 yr sac reduction = 8mm
20 Clinical and Regulatory Status OVATION CE Mark received August 2010 OVATION PRIME CE Mark received June 2012 Enrolling in a 500 patient European post market registry Excellent year results across a clinically challenging cohort of patients Over 1,300 patients treated worldwide FDA PMA Approval, OVATION, October, 2012 FDA PMA-S Approval, OVATION PRIME, December 2012
21 Why Another EVAR Device... Ovation safely and effectively addresses previously unmet clinical needs Ovation s IFU expands the pool of patients eligible for EVAR Ovation is next generation EVAR technology available TODAY
22 14F OD Ovation Abdominal Stent Graft System 2 Year Results from the European Study Dierk Scheinert, MD Center for Vascular Medicine Angiology and Vascular Surgery Park Hospital Leipzig, Germany
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