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
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
Why Another EVAR Device?
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
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
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
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
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
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)
Anatomical Characteristics Aortic Neck Length (n=30) 23% of treated aortic necks shorter than 15mm 12 10 8 7 11 7% were < 10mm in length 6 4 2 2 5 5 0 <10 mm 10-14.9mm 15-19.9mm 20-24.9mm 25 mm Minimum Access Vessel Diameter (n=30) 47% of patients treated had an access vessel < 7mm in diameter 10 8 6 8 6 8 8 Minimum diameter access vessel treated = 3.2mm 4 2 0 6mm 6.1-7mm 7.1-8 mm >8 mm
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.
Primary Safety Based on Clinical Events Committee (CEC) adjudicated data SAFETY 0-30 Days 31-365 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
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.
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.
Expanding EVAR Safely
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
Hostile Neck - Difficult Access:
12 m f/u:
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
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
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
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