risultati a distanza dell’endoprotesi ovation · risultati a distanza dell’endoprotesi ovation...

RISULTATI A DISTANZA DELL’ENDOPROTESI OVATION

©2016 Endologix, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

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SONIA RONCHEY MD PhDSAN FILIPPO NERI - ROMA

Ovation

>10000 patients treated with the Ovation platform

• Expanding global reach to patients with straight-forward to challenging anatomy with an easy to use system

2

Confidential. For Internal Use Only.

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OVATION OVATION PRIME OVATION iX OVATION ALTO

2010 2011/2012 2014 ?2018/2019

The Ovation® System is approved to treat infrarenal abdominal aortic aneurysms and is not approved for any other intended use in any geography.The Ovation® Abdominal Stent Graft Platform and associated components are not available in all countries or regions.

Please contact your Endologix representative for details regarding product availability. Prior to use, refer to the “Instructions for Use” for complete and specific indications, contraindications, all warnings and precautions. Rx only.

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Ultra low profile path to durability with a patient-specific seal

VALIDATION THROUGH CLINICAL EVIDENCE IN 1,500+ PATIENTS

36 Centers US, Chile, Germany

5 Year Results

30 Centers3 Year Results

FAST Track EVAR40 Centers30d Results

US 39 CentersEU 12 Centers

Enrolling

Alto IDE and PMR Enrollment starting

in 2017

161patients

501patients

250patients

285patients

375patients

The Ovation Alto is not approved in any market; Ovation Alto is an investigational device in the United States, limited by federal (or United States) law to investigational use only.



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United States GermanyChile

161 patients enrolled in Chile, Germany and USA from Nov 2009 – Dec 2011

• First Global Pivotal Trial • Broadest Indication Statement • First-in-Human / No roll-in at All Sites

Ovation® Global Pivotal Trial

Botti, Charles Riverside Methodist Hospital

Cheema, Mohiuddin

Hartford Hospital

Clair, Daniel Cleveland Clinic

Eidt, John Central Arkansas VA

Eskandari, Mark Northwestern Memorial

Glickman, Mark Sentara Medical Group

Gray, Bruce Greenville Hospital

Haser, Paul UMDNJ

Hassoun, Heitham Methodist Hospital

Henretta, John Mission Hospital

Hodgson, Kim Southern Illinois University

Jain, Ash Washington Hospital

Jicha, Douglas Santa Rosa Memorial

Jones, Paul Mercy Medical Center

Jordan, William UAB

Kasirajan, Karthik Emory University

Krajcer, Zvonimir St. Luke’s Hospital

Laird, John UC Davis

Maini, Brijeshwar Moffitt Heart and Vascular

Makaroun, Michel UPMC

Maldonado, Thomas NYU Hospital

Mehta, Manish Albany Medical Center

Mishkel, Gregory Prairie Heart

Moore, Wesley UCLA

Motew, Stephen Forsyth Medical Center

Murkherjee, Dipankar Inova Fairfax Hospital

Rizvi, Adnan Minneapolis Heart Institute

Sternberg, Charles Ochsner Health System

Valdes, Francisco Catholic University

Brunkwall, Jan Uni. Klinik Koln

Krankenberg, Hans Medizinisches Versorgungszentrum, HH

Mathias, Klaus Klinikum Dortmund

Nolte, Thomas Herz und Gefaßzentrum, Bad Bevensen

Scheinert, Dierk Park Krankenhaus, Leipzig

Sievert, Horst CVC, Frankfurt

Torsello, Giovanni St. Franziskus-Hospital, Münster



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Anatomical Characteristics

69% of patients had one or more hostile neck anatomies; 31% had small access vessels

None; 31%

One; 36%

Two,

Three; Hostile Neck Characteristics N=161

Neck angle ≥60° 3.1% (5)

Neck Length <10mm 16.1% (25)

Neck Diameter ≥28mm 5.6% (9)

Reverse Taper 26.7% (43)

50% Circumferential Calcium/Thrombus ≥2mm 62.1% (100)

Access Vessel Characteristics

Minimum Access Vessel <6mm 31% (50)

Number of Hostile Neck Characteristics per patient

Ovation Pivotal Trial data as of August 2, 2016



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Adjunctive Devices for Proximal Seal

Adjunctive Proximal Device 3.2%

LIFE RegistryOvation iX

CASE EXAMPLE▪ Palmaz stent used to address

intraoperative Type1a endoleak due to undersized graft.

▪ 3 year follow-up shows no neck dilatation. Palmaz stent and sealing ring maintain wall apposition.



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Type Ia Endoleak Intervention through 5 Years

97% Five Year Freedom from

Reintervention for Type 1a Endoleak




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Type II Endoleak

Type II EndoleakOvation

Pivotal Trial - GlobalOvation

Pivotal Trial - US Endurant IDE Zenith IDE Excluder IDE

Core Lab – at 5 Yr 28.8% 23% 7.2% 4.3% 12.3%

Reintervention – 5 Yr 9.9% 8.1% 6.7% 11.0% 7.1%

Reintervention through 5 Years for Type II Endoleak in line with EVAR

• Ovation Trial recommended smaller (0.6mm-2.0mm) CT slices (vs. 3-5mm slices in other EVAR trials);• Median core-lab adjudicated type II endoleak volume at 1 year was 1 mL;

• For comparison, mean volume of type II endoleaks that undergo intervention is 7 mL;• Those that require no intervention average 4 mL

Mehta et al. J Vasc Surg 2014;59:65-73Keedy et al. AJR 2011;197:234-240




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Freedom from Reintervention through 5 Years

97% for type I endoleak96% for occlusion90% for type II endoleak84% for all reintervention

US Cohort - Pivotal Trial




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Freedom from Mortality through 5 Years

98% Five Year Freedom from ARM

75% Five Year Freedom from ACM




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Risk of Aortic Neck Dilatation with EVAR

Increased size

of aorta

24.6%Neck Dilation

incidence of clinical events with dilation Type Ia endoleak, migration, and reintervention

26%

over a 15 month to 9 year period

vs 2% Without dilation

SELF EXPANDING STENT GRAFT

Chronic outward force from stent, combined with blood pressure, can result in aortic neck dilatation.



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3Core Lab evaluation, Ovation Global Pivotal Trial. N=94. Data as of Aug 2, 2016 4Neck dilation = growth > 3mm at 10mm, 13mm, and 15mm below renals

Aortic Neck Dilatation with Ovation®

1Monahan JVS 2010: 52: 303-7. N=46. Devices: Cook Zenith 2Rodway EJVES 2008;35:685-93 EVAR: N=67, Open N=56. Data to 2 years.

STABLE NECK DIAMETER

THROUGH 5 YEARS


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Conclusion• Non-expansive circumferential wall apposition of

sealing ring creates no chronic outward radial force • No aortic neck dilatation is expected.

161 patientsMedian 32 months (range 24-50)

Zone B & C - No Neck enlargement (≥2mm)- No Stent graft migration(≥3mm)

At 2y follow-up the mean change in

diameters was -0,06 ± 0.97 mm (SE

0,1)

J Vasc Surg. 2016 Jan;63(1):8-15



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Ovation Pivotal Trial

Endurant IDE Zenith IDE Excluder IDE

Patients Enrolled 161 / 111 US 150200 / 100

Std Risk / High Risk565

ASA Class III /IV 60% / 7% 49% / 0% NR NR

Major Adverse Event 0-30d / 31-365d 2.5% / 3.8% 4.0% / 6.5% NR 5.7% / 5.1%

Freedom from Conversion 100% 100% 98% / 98% 97%

Freedom from Rupture 99% 99% 100% / 99% 99%

Freedom from AAA-Related Mortality (5 Yr) 98% 99% 99% / 94% 98%

Freedom from All Cause Mortality (5 Yr) 75% 83% 83% / 58% 70%Results for EVAR commercially available devices shown per the respective US FDA Summary of Safety and Effectiveness Data (SSED) and Annual Clinical Reports.

Adverse Events

Lowest Reported MAE Rate Across US Pivotal Trial Cohorts for FDA-Approved AAA Devices




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• REAL WORLD PERFORMANCE

• Multicenter, prospective

• 501 patients, 30 EU sites

• Patients enrolled May 2011 – Dec 2013

• Ovation Prime and Ovation iX

OVATION® EUROPEAN

POST MARKET REGISTRY

• 3-Year Results Presented at LINC 2017



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1/3 OF PATIENTS HAD COMPLEX MORPHOLOGY

Min EIA Dia <7mm; 41,6%

Neck Dia ≥28mm; 12,8%

Neck Angle ≥60°; 4,3%

Neck Length <10mm; 5,3%

Severe Neck Calcification;

3,0%

Severe Neck Thrombus;

5,5%

Storck et al JCVS 2016 Gender Differences in Ovation EU PMR



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Procedural Outcomes

59%

39% N=501

Technical Success (successful deployment of

device)99.8%

Polymer leak with anaphylactic shock 0.2%

Anesthesia Time (mean) 150 minutes

Procedure Time (mean) 51 minutes

Fluoroscopy Time (mean) 22.2 minutes

In the Ovation study, subjects undergoing percutaneous access achieved similar clinical outcomes with low time spent related to anesthesia, procedure and fluoroscopy.

Cutdown

Percutaneous

3% Percutaneous and Cutdown

Ovation EU PMR data as of October 6, 2016



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One contained rupture, day 30, from Type Ib endoleak. Treated with hypogastric occlusion and iliac limb extension.

Three conversions: day 88 due to aortic occlusion, day 449 due to Type I/II endoleak, and 477 due to aorto-enteric fistula

99%

Freedom from Conversion

99%

Freedom from Rupture

DURABLE RESULTS THROUGH 3 YEARS




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97% Freedom from

Type I Endoleak

99% Freedom from

Type III Endoleak

DURABLE RESULTS THROUGH 3 YEARS




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FREEDOM FROM 3 YEAR REINTERVENTION

97% for Type I Endoleak 95% for Type II Endoleak 97% for Occlusion




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FREEDOM FROM 3 YEAR MORTALITY

99% Freedom from AAA-Related Mortality

88% Freedom from All Cause Mortality




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Ovation EU PMR

Medtronic ENGAGE

Patients Enrolled 501 1262

ASA Class III/IV 48.5% 52.1%

AAA-Related Mortality 0.4% 1.5%

All Cause Mortality 12.8% 19.8%

Rupture 0.2% 0.5%

Conversion 0.8% 0.9%

Type I/III Endoleak at 3 years 0.9% 1.5%

Type I/III Endoleak through 3 years 3.2% nr

Reintervention for Type I/III Endoleak 3.6% 3.0%

Reintervention for Type II Endoleak 4.6% nr

Occlusion 2.0% 3.9%Ovation data are site reported. Three year ENGAGE results excerpted from ENGAGE 4-Year Results Presentation, Sambeek et al. VEITH Symposium, November 2015

POST MARKET REGISTRIES: OVATION vs. ENDURANT




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• More women than men are ineligible for EVAR• Inadequate neck length• Narrow access vessels

• Women are underrepresented• Enrollment of women in cardiovascular clinical

trials is disproportionately low

• Outcomes in women are worse- Arterial injuries, longer LOS, higher readmission

rates, greater mortality

WOMEN WITH AAA: AN UNDERSERVED POPULATION

1Morrison T, Fillinger M, Meyer C, et al. Gender disparities in endovascular treatment options for infrarenal abdominal aortic aneurysms.http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM359044.pdf. Published June 25, 2013.



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GENDER SUB-ANALYSIS: 432 MEN, 69 WOMEN

38%

12%

4% 4% 3% 6%

65%

17%10% 12%

2% 5%

0%

10%

20%

30%

40%

50%

60%

70%

Min EIA Dia<7mm

Neck Dia ≥28mm

Neck Angle ≥60°

Neck Length<10mm

Severe NeckCalcification

Severe NeckThrombus

Male Female




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Three Year OutcomesMen

N=432

Women

N=69P-Value

Freedom from AAA mortality 99% 100% 0.57

Freedom from All-Cause Mortality 87% 90% 0.77

Freedom from Type I Endoleak 97% 94% 0.003

Freedom from Type III Endoleak 99% 100% 0.42

Freedom from Occlusion 99% 94% 0.003

Freedom from Conversion 99% 99% 0.32

Freedom from Rupture 99% 100% 0.69

Freedom from Aneurysm Enlargement ≥5mm 93% 91% 0.59

WOMEN AND MEN DERIVED SIMILAR OUTCOMES




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AAA-RELATED REINTERVENTION

Reason for

Reintervention

Men

N=432

Women

N=69P-Value

Type Ia 2.1% (9) 4.3% (3) 0.08

Type Ib 1.2% (5) 1.4% (1) 0.10

Type II 4.2% (18) 13% (9) 0.08

Type III 0.5% (2) -- na

Occlusion 2.5% (11) 4.3% (3) 0.03

Stenosis 0.9% (4) 1.4% (1) 0.18

Limb Migration 0.7% (3) 1.4% (1) 0.32

Infection (AEF) 0.2% (1) -- na




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FREEDOM FROM MORTALITY THROUGH 3 YEARS

Freedom from ARM

99% Men100% Women

Freedom from ACM

87% Men90% Women

P=0.7682P=0.5717




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FREEDOM FROM ENDOLEAK AND OCCLUSION THROUGH 3 YEARS

Freedom from Occlusion

98% Men94% Women

P=0.0027P=0.0225

Freedom from Type I Endoleak

97% Men94% Women

P=0.0028

Freedom from Type III Endoleak

99% Men100% Women

P=0.4217




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FREEDOM FROM RUPTURE AND CONVERSION THROUGH 3 YEARS

Freedom from Rupture

99.7% Men100% Women

Freedom from Conversion

98.5% Men99.5% Women

P=0.6894 P=0.3244




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FREEDOM FROM SAC GROWTH THROUGH 3 YEARS

Freedom from AAA Growth >5mm

93% Men91% Women

P=0.5917

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Clinical Evidence to Validate the Ovation® Platform

• Over 10,000 patients worldwide have been treated with the Ovation Platform,

with over 1,500 subjects in a tightly controlled study or registry

• Patient demographics, anatomical characteristics, and procedural

characteristics indicate a challenging patient cohort.

• Short-term results show lower major adverse events, faster discharge, and

fewer readmissions compared to traditional EVAR

• Mid-term results show low rupture and conversion rates, low Type I / III

endoleaks, and stable aortic neck diameter

• Women and men derive similar benefits with Ovation through 3 years

• These data provide compelling evidence that the Ovation system can expand

EVAR access to more patients and improve EVAR outcomes for all patients

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14M

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07

SE

P3

5-V

A

22

SE

P38

-RA

27M

AY

34-B

C

06

FE

B3

8-C

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28

AU

G3

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Personal

Experience

Patients 112Gender (Male/Female) 99/11

Mean Age (years)

(Range)

74,6 (55-91)

Proximal neck diameter 24.6(18.2-30.1)

Proximal neck lenght15.6

(4.3 -30)

Aneurysm 50.8(34.5-75.0)

Iliac (R/L)13.7/13.6

(8.9-20.7/7.1-20.5)

Access vessels (R/L)7.4/7.1

(3.9-11.6/3.4-10.2)

Delta aorta - aneurysm 60%(40-65%)

Device Time (min)45

(25-70)

Personal

experience

Personal

experienceOVATION 26

OVATION PRIME 69

OVATIONiX 17

Personal experience: 112 PTS

39

10%

65%

39%

55%

1%

28%

NeitherCriteria

Dirty Angled Flared Tapered Short

Aortic Neck


20%

35% 32%

68%Iliacs Arteries


100% percutaneous

97% under local anesthesia



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• Percutaneous Access• No General Anesthesia• No ICU Admission• Next-day Discharge

TO SAFETY, FASTER DISCHARGE, AND FEWER READMISSIONS

ULTRA LOW PROFILE PATH…..

Ovation LIFE EVAR Traditional EVAR

MAE 0.5% 3-4%

Procedure Timemin 84 110

ICUdays 0 1.4

LOSdays 1.2 2.9

30-day Readmission 1.6% 8%

30-day results

3,4

2

2

1

1. 30d MAE rates for commercially available EVAR devices per US FDA SSED reports and post market global registries. Data on file. 2. Premier EVAR. 3. Chen SL et al. Perioperative Risk Factors for Readmission Following EVAR. Presented at SCVS, 2016. 4. Gupta PK, et al. Unplanned readmissions after vascular surgery. J Vasc Surg 2014;59:473-82.

2

LIFE data as of August 2, 2016

Narrow/Tortuous Access vassels

Thrombus atsealing zone

Calcification at Bifurcation (10x13 mm)

Male

70-75 years

Neck Diameter 18.9mm

Aneurysm Diameter 45.9mm

Iliac Diameters R: 9.6mm

L: 10.0mm

Access Diameters R: 4.9 mm

L: 5.1 mm

Access

Tortuosity

Difficult Access - Result

Post Procedure 12 Month Follow-upPre Procedure

Absence of nitinol skeleton implies even:

- Risk of limb collapse in case of tight luminal space

- Risk of kinking in angulation

- Risk of limb occlusion

46

Small/Diseased iliac arteries : previous

stenting on the left side

47

After 5 daysPost ProcedurePre Procedure

48

5 days after …. R-Branch occlusion Recanalization & STENTING

Intra PostPre

LESSON LEARNED

BALLOONING &/OR STENT

RELINING

TO BE DONE IMMEDIATELY!!

Personal experience: 112 pts

Immediate complications▪ Bleeding

1 §

▪ Polimer extravasation 1 §

(allergic reaction – no sequaele)

▪ Endoleak type I 3 * (2 TREATED – 1 SELF SEALED)

▪ Branch occlusion 1 * (TREATED)

49

§ OVATION 2010-12

Immediate results

– Death11

• TYPE A DISSECTION 1

– Type I EL 1*

– Type II EL35*

– Branch occlusion 1 **

• * TREATED (CHIMNEY + CUFF)

• ** TREATED

• * 40% in case of diseased iliac

late results

Mean f-up 42,8 (0-84 mths)

Personal experience: 112 pts

CONCLUSIONS

Ovation safely and effectively addresses previously unmet clinical needs

Good immediate resuts

Good mean and long term results

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