TriVascular Ovation Prime Abdominal Stent Graft System with the Ovation … · * Device D data from...
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TriVascular Ovation Prime ® Abdominal Stent Graft System with the Ovation iX™ Iliac Stent Graft ©2015 TriVascular, Inc. All Rights Reserved. CE Marked. Please refer to current product Instructions for Use. 830-0115-02rC
Transcript of TriVascular Ovation Prime Abdominal Stent Graft System with the Ovation … · * Device D data from...
TriVascular Ovation Prime®
Abdominal Stent Graft Systemwith the Ovation iX™ Iliac Stent Graft
©2015 TriVascular, Inc. All Rights Reserved. CE Marked. Please refer to current product Instructions for Use. 830-0115-02rC
Problems with Commonly Used Stent Grafts
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Hostile necks, thrombus and
calcium prevent an effective seal
Prior to the Ovation® system, the
majority of stent grafts had an
indication to treat necks >15mm. One
stent graft indicated to treat necks
>10mm.
• Narrow and tortuous iliac arteries preclude access to treatment area
• Prior to the introduction of the Ovation®
system, the lowest OD profile was 18F OD for the main body on smaller sizes and 19F-21F OD on the majority of sizes. Im
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Low Profile, Expanded Options
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Tortuous Anatomy
Narrow Access
4.9 mm5.1 mm
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* Patient’s Access Vessel Size Distribution
(Derived from M2S Measurement Database of 43,000 CT Scans)
Device E: 20F OD
Addresses 40% of AAA population*
Devices C and D: 18F OD
Addresses 59% of AAA population*
TriVascular Ovation Prime 14F OD,
Device A
Addresses 83% of AAA population*
Device F: 22F OD
Addresses 27% of AAA population*
Device B: 17F OD
Addresses 63% of AAA population*
Ovation System
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At 14F, the ultra-low
profile system enables
smooth access to the
aneurysm
Staged deployment of
suprarenal stent allows
simple, precise placement
Polymer-filled sealing ring
creates a custom seal and
protects the aortic neck
Low permeability
PTFE enables
effective aneurysm
exclusion and
device patency
Conformable, kink resistant
iliac limbs designed to reduce
risk of occlusion
Ovation System Expands EVAR
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TriVascular
Ovation Prime
& iX Iliac
Limbs
Device A Device B Device C Device D Device E Device F
Key Indications
Proximal Neck
Length
No conventional
neck length
requirement
≥ 10mm ≥ 10mm ≥ 10mm ≥ 15mm ≥ 15mm ≥ 15mm
Proximal Neck
Angle
(Degrees)
<60 if neck
length ≥ 10 mm
≤ 45 if neck
length < 10 mm
< 60 < 60 < 60 ≤ 60 ≤ 60 ≤ 90
Neck Diameter16-30mm
Inner Wall
17-31mm
Not Specified
16-32mm
Not Specified
19-32mm
Inner Wall
18-28mm
Outer Wall
19-32mm
Inner Wall
19-33mm
Inner Wall*
Iliac Diameter8-25mm
Inner Wall
7-22mm
Not Specified
8-35mm
Not Specified
8-25mm
Inner Wall
8-20mm
Outer Wall
8-25mm
Inner Wall
9-19mm
Inner Wall*
Device Features
Profile OD
(main body)14F-15F 14F-16F 17F 18F-20F 18F 20F 22F
*In healthy landing zones. Measurement is outer wall to outer wall in diseased landing zones.
Ovation Global Pivotal Trial3 Year Results
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Safety2 0 to 30 Days 31 to 365 Days 366 to 730 Days 731 to 1095 Days
Major Adverse Events 2.5% (4/161) 3.8% (6/159) -- --
Device Related Major Adverse Events 0.0% (0/161) 0.0% (0/159) -- --
Rupture 0.0% (0/161) 0.0% (0/159) 0.0% (0/154) 0.0% (0/138)
Conversion to Open Repair 0.0% (0/161) 0.0% (0/159) 0.0% (0/154) 0.0% (0/138)
Limb Occlusions3
0.6% (1/161) 0.6% (1/159) 0.0% (0/154) 0.7% (1/138)
Effectiveness4 30 Day 1 Year 2 Years 3 Years
Type I and III Endoleaks 0.0% (0/153) 0.0% (0/143) 0.0% (0/121) 0.0% (0/106)
Migration Baseline 0.0% (0/150) 0.0% (0/133) 0.0% (0/113)
A pivotal clinical study to evaluate the safety and effectiveness of the TriVascular Ovation
Abdominal Stent Graft System.
Technical Success1 All
Defined as successful, delivery and deployment of one aortic body and two iliac limbs 100.0% (161/161)
Data as of July 25, 20141Technical Success based on investigator reports2 Major Adverse Events and Device Related Major Adverse Events based on Clinical Events Committee (CEC) adjudicated data. Rupture and Conversion to Open Repair
based on investigator reports3Re-interventions due to limb occlusion4 Endoleaks and Migration rates based on Core Lab Data (M2S)
Expanding EVAR SafelyChallenging Subgroup Analysis
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~40% (66/161) of Ovation Trial
patients treated had access vessels
<6mm, aortic neck length <10mm, or
both.
The Ovation System’s ultra low profile and advanced
sealing technology produced excellent results in this
anatomically challenging subgroup.
Minimum Access Vessel <6mm25%
Neck Length <10mm
8%
Both Criteria
8%Neither Criteria
59%
Safety1 0-30 Days31-365
Days
366-730
Days
731-1095
Days
Major Adverse Events 0.0% (0/66) 3.0% (2/66) -- --
Device Related MAEs 0.0% (0/66) 0.0% (0/66) -- --
Rupture 0.0% (0/66) 0.0% (0/66) 0.0% (0/63) 0.0% (0/53)
Conversion to Open Repair 0.0% (0/66) 0.0% (0/66) 0.0% (0/63) 0.0% (0/53)
Limb Occlusions2
1.5% (1/66) 0.0% (0/66) 0.0% (0/63) 0.0% (0/53)
Effectiveness3 30 Days 1 Year 2 Year 3 Year
Type I and III Endoleaks 0.0% (0/64) 0.0% (0/59) 0.0% (0/48) 0.0% (0/36)
Migration Baseline 0.0% (0/62) 0.0% (0/54) 0.0% (0/41)
Data as of July 25, 20141Major Adverse Events and Device Related Major Adverse Events based on Clinical Events
Committee (CEC) adjudicated data. 2Re-interventions due to limb occlusion or stenosis3 Endoleaks and Migration rates based on Core Lab Data (M2S)
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Low Profile Device Well Suited for Percutaneous Access
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Cut-down57%
Percutaneous43%
Access Type
Cut-Down Percutaneous
Major Adverse Event @ 30 Days 3.3% (3/92) 1.4% (1/69)
Treatment Success @ 1-year 98.9% (91/92) 100% (69/69)
Anesthesia Time (mean) 191 minutes 149 minutes
Procedure Time (mean) 118 minutes 98 minutes
Hospitalization (median) 2 days 1 day
In the Ovation pivotal study, subjects undergoing
percutaneous access achieved similar clinical outcomes
with slightly lower time spent related to anesthesia,
procedure and hospitalization time.
Ovation System Protects the Neck
Ovation Prime sealing ring creates no chronic outward force and
insulates the neck from blood pressure, resulting in no neck dilatation
and no late Type 1 endoleaks at 3 years3,4
1 Monahan JVS 2010: 52: 303-7 N=46. Devices: Cook Zenith 2 Rodway Eur J Endovasc Surg 2008; 35: 685-93; Open: N=56. Data available for up to 2 years.3 Neck dilatation in proximal neck defined as growth > 3mm at 10mm below renals, 13mm below renals, and 15mm
below renals; measurement methodology in Ovation Pivotal Trial similar to measurement methodology in cited studies4 Ovation Global Pivotal Trial N=131
Aortic Neck Dilatation Over Time
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Primary Safety Data Comparison
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TriVascular
Ovation IDEDevice C Device D* Device E Device F
Patients Enrolled 161 150 120 565 218
MAE,
0-30 days2.5% 4.0% 0.8% 18.6% 24.3%
MAE,
31-365 days 3.8% 6.5% 6.2% 17.1% Not Reported
Device-Related MAE,
0-365 days0% Not Reported Not Reported 10.6% Not Reported
All-Cause Mortality,
0-30 days 0.6% 0% 0% 1.0% 1.8%
All-Cause Mortality,
31-365 days1.9% 4.3% 4.4% 7.0% Not Reported
Sources: Data rates from Instructions For Use (IFU)
* Device D data from SVS Podium Presentation in June 2012
Note: PMA data not available for Device A or Device B
Additional Data Comparison
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TriVascular
OvationDevice C Device D1 Device E Device F
Patients Enrolled 161 150 120 565 218
Type I Endoleak 0% 0% 0% 0.8% 0.7%
Type III Endoleak 0% 0% 0% 0.9% 0.7%
Migration 0% 0% 0% 0.7% 1.2%
AAA Rupture2 0% 0.8% 0% 0% 0.5%
Conversions2 0% 0% 0.8% 1.1% 1.8%
Freedom from Sac
Enlargement99.3% 100% 98.3% 95.0% 98.8%
Limb Occlusions2 1.2% 2.7% 7.7% 0.4% 3.7%
Subjects Requiring
Re-interventions2 6.2% 6.7%3 Not Reported 11.5% 15.6%
One Year, based on Core Lab Data
Sources: Ovation data as of June 6, 2012. Data Rates from Instructions For Use (IFU) and Annual Clinical Updates
1- Device D data from SVS Podium Presentation in June 2012
2- Based on Investigator Reported Events
3- Source: Makaroun M. One-year outcomes of the US regulatory trial of the Endurant stent graft system. J Vasc
Surg. 2011;54:601–608. Includes re-interventions on Day 0.
Note: PMA data not available for Device A or Device B
Procedure Data Comparison
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TriVascular
OvationDevice C Device D* Device E Device F
Patients Enrolled 161 150 120 565 218
Technical Success 100% 99.3% 100% 99.6% 96.3%
Mean Duration of
Procedure, minutes110 102 Not Reported 143 173
Percutaneous Access 42.9% Not Reported 30.0% 9.7% 18.1%
Subjects Receiving
General Anesthesia 66% 83% Not Reported Not Reported 83%
Sources: Data rates from Instructions For Use (IFU) and Company Marketing Materials.
* Device D data from SVS Podium Presentation in June 2012
Note: PMA data not available for Device A or Device B
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INDICATIONS FOR USE: The TriVascular Ovation/Ovation Prime Abdominal Stent Graft Systems are indicated for treatment of patients with abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair, including: adequate iliac/femoral access compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and/or accessories; proximal aortic landing zone: with an inner wall diameter of no less than 16 mm and no greater than 30 mm at 13 mm below the inferior renal artery, and with an aortic angle of ≤ 60 degrees if proximal neck is ≥ 10 mm and ≤ 45 degrees if proximal neck is < 10 mm; distal iliac landing zone: with a length of at least 10 mm, and with an inner wall diameter of no less than 8 mm and no greater than 20 mm.
The Ovation Prime Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft are indicated as stated above with a distal iliac landing zone inner wall diameter no greater than 25 mm.
CONTRAINDICATIONS: The systems are contraindicated for use in patients who have a condition that threatens to infect the graft and in patients with known sensitivities or allergies to the device materials (including polytetrafluoroethylene [PTFE], polyethylene glycol [PEG]-based polymers, fluorinated ethylene propylene [FEP] or nitinol). Also consider the information in Section 4 Warnings and Precautions of the systems’ Instructions for Use.
Refer to Instructions for Use at TriVascular.com for more information concerning Indications, Contraindications, Warnings and Precautions, and Adverse Events.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
CE marked. Please refer to current product Instructions for Use.
