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Initial Clinical Experience with the Ventana™ ‘Off-the-Shelf’ Fenestrated Stent Graft System Daniel G. Clair, MD, FACS Chairman, Department of Vascular Surgery

MM0204 Rev .01


Disclosure  Endologix, Inc. scientific advisor


The Unmet Clinical Need  Short or No Infrarenal Neck (~25% of AAA Pts) • Juxtarenal Aneurysms (JAA) • Pararenal Aneurysms (PAA) • Thoracoabdominal Aneurysms

 Current Treatment Options • Open Surgery • Other Techniques o Hybrid debranching o Chimney/snorkel off-label device use • Custom Device*

*CE Marked/investigational device in the US. Indicated for short neck/juxtarenal aneurysms


Open Repair Outcomes •Reference Single Center Reports 30-Day Mortality

Renal Dysfunction

Sarac 2002

5.1%

28%

Shortell 2003

6.3%

12%

Chiesa 2006

4.2%

19%

West 2006

2.5%

22%

Knott 2008

0.8%

18%

 NIS Meta Analysis (vs.

infrarenal open repair)*

• 30-day mortality: 5.8% vs. 4.4%, P<.001 • Acute renal failure: 9.5% vs. 6.0%, P<.001 *Martin M et al. Ann Vasc Surg 2010;24:106-12.


Pooled Analysis of F-EVAR

Parameter

Open Repair

F-EVAR

P

N

1164

368

---

Male gender

83%

86%

.09

74

72

<.0001

Renal disease

22%

24%

.5

30-Day mortality

3.6%

1.4%

.02

Renal impairment

20%

15%

.03

---

5.6%

---

2.6%

15%

.0001

Age, years

Primary Type I/III endoleak Early re-intervention

Eur J Vasc Endovasc Surg 2009;38:35-41.


The Next Horizon for F-EVAR…

 Non-custom, ‘off-the-shelf’ device  Fully integrated system with renal stent grafts  Applicable to broad patient anatomy


Endologix Ventana™ System  Ventana™ stent graft with Xpand™ renal stent grafts

 Anatomically fixed unibody bifurcated stent graft


Design Fit to Anatomy • Characterization of visceral artery Measurement Min geometries Max (M2S) Distance: RRA to SMA

-8.9mm

43mm

Distance: LRA to SMA

-8.0mm

47mm

Distance: Celiac artery to SMA

-36mm

24mm

Angle: RRA to SMA

32

116

Angle: LRA to SMA

31

118

Angle: RRA to LRA

mean 151

 External validation (CCF open repair pts - JAA/PAA/TAA) • Confirmed M2S geometry data analysis • >80% of visceral anatomies treatable with Ventana™


Ventana System Design Features  Foundation - Anatomical Fixation

 Off the Shelf Design •

Renal artery fenestrations – movable in situ • Proximal scallop (SMA/celiac) • Applicability to broad range of anatomical configurations (>80% of JAA/PAA)

 Fully Integrated System •

Pre-loaded 6.5Fr sheaths for RA cannulation • Endologix renal stent grafts • Delivery system proprietary features


Ventana System Design Features  Two 3mm diameter renal fenestrations with 6.5Fr renal sheaths pre-loaded through the fenestrations

 Fenestrations can be expanded up to 10mm to accommodate a range of renal artery diameters

 Renal fenestrations can be moved up to 35mm from their nominal locations

 There is a 4cm deep scallop for the CA and SMA with side and central radiopaque markers


Ventana System Design Features


Anatomic Eligibility Criteria        

Infra-renal aortic neck <15mm Infra-SMA aortic neck length ≥ 15mm Infra-SMA aortic neck diameter 18-34mm CA and SMA separated by ≤ 60o (clockface) Both renal arteries at or ≤ 35mm below SMA Renal arteries separated 90o to 210o (clockface) SMA to aortic bifurcation ≥90mm Lowest renal artery to aortic bifurcation ≥70mm


Device Sizing: Infra-SMA Aortic Neck  Infra-SMA aortic neck length ≥ 15mm

 Infra-SMA aortic neck diameter 18 - 34mm


Device Sizing: Renal Artery Locations  The renal artery locations are independent from the Infra-SMA sealzone

 Renal arteries are 90° to 210 ° (clockface) apart

Juxtarenal Aneurysm

Pararenal Aneurysm Anterior to LRA

+ Anterior to RRA = Renal to Renal Angle


Device Sizing: Renal Artery Distances  Renal arteries with 30mm of each other*

 Renal arteries both at or below SMA ≤35mm* SMA to LRA

SMA to RRA

*Centerline measurements


Ventana Case #1  71 year old male, previous history of PAD  5.5cm AAA, 4.5mm long infrarenal neck


Step 1: Deploy Bifurcated Stent Graft ď&#x201A;§ Deploy on the aortic bifurcation with anatomic fixation ď&#x201A;§ Top end of this device is landed 1-3cm below lowest renal artery


Step 2: Introduce Ventana Device ď&#x201A;§ Device delivered through ipsilateral side ď&#x201A;§ Compliant balloon (e.g., Cook CODA) inflated in contralateral limb of bifurcated


Step 3: Retract the Outer Sheath ď&#x201A;§ Retract outer sheath until the RO markers of the 6.5Fr renal sheaths are exposed 1-2cm below the renal arteries ď&#x201A;§ Can retract down to the safety clip on the inner core


Step 4: Cannulate Each Renal Artery  A key feature of the Ventana device is that it is fully constrained while the renal arteries are cannulated  This stable platform plus a range of shaped catheters allows cannulation of even difficult renal artery anatomies  This is a major point of difference with this device


Step 5: Advance Renal Sheaths  Catheters advanced into renal arteries  Guidewires exchanged for stiffer wires (e.g. Rosen)  6.5F sheaths advanced into renal arteries


Anterior

RA Oblique

Posterior


Step 6: Advance Device to Deploy ď&#x201A;§ Device advanced so that the base of SMA scallop (RO marker) lies close to the SMA ď&#x201A;§ Proximal section deployed in the lateral position


Step 7: Deploy Proximal Section  Proximal section deployed by advancing a pusher rod  May initially deploy the device a little high so that the RO marker partly covers the SMA  Can easily pull the whole device down into perfect position


Step 8: Deploy Distal Section  Safety clip removed  Outer sheath retracted to deploy the distal section


Step 9: Deploy and Flare Covered Renal Stents ď&#x201A;§ Renal stent grafts positioned so that ~5mm (two stent elements) project into the aortic lumen ď&#x201A;§ Stents flared in the aortic section


Endologix Renal Stent Graft  Intended for Vessel Diameters of 4 to 8mm  Used Since Study Case #5


Step 10: Completion Angiography ď&#x201A;§ Delivery system removed ď&#x201A;§ Completion angiography performed


Pilot Study Overview  12 Cases Completed at Two Centers • Auckland, New Zealand N=8 • Santiago, Chile N=4

 Study Primary Analysis at 30 Days • Procedural Technical Success without Type I/III Endoleak as

determined by independent Core Lab • Major Adverse Events* • Renal Function • Device Performance and Aneurysm Morphology

 Continuing Follow-up to 5 Years *Defined as death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory complications, stroke, or blood loss >1000mL.


Baseline Demographics and Risk Factors Parameter Male Gender

Result (N=12) 83%

Age, years

79 5.0

eGFR (calculated)

56 14

Smoking (ever)

60%

Hypercholesterolemia

60%

Hypertension

50%

Arrhythmia

40%


Baseline Anatomical Measures Parameter

Mean SD

Min, Max

(N=12)

Maximum aneurysm sac diameter, cm

5.6 0.3

5.0, 6.2

Infra-SMA neck length, mm

25 13

8, 44

Infra-SMA neck diameter, mm [proximal]

24 1.9

21, 27

Neck to aneurysm sac angle, o

36 15

13, 57

Left to right renal artery angle (clock face), o

146 24

122, 204

SMA to Celiac artery angle (clock face), o

14 10

1.5, 30

Renal artery diameter, mm

5.8 1.2

3.0, 8.0

Results shown as mean Âą SD [min, max] â&#x20AC;&#x201C; based on Core Lab Measurements


Procedural and In-Hospital Outcomes Parameter

Mean

SD

Min, Max

(N=12)

Fluoroscopy Time, min

58 23

28, 104

Contrast Volume, mL

295 106

80, 420

Blood Loss, mL

518 366

200, 1500

Procedure Time, min

112 37

78, 212

2.9 2.4

1, 8

Results shown as mean (range) or median

Time to Hospital Discharge, days

ď&#x201A;§ Technical Success = 100%

ď&#x201A;§ No mortality; aneurysm rupture; conversion to open repair; or Type I/III endoleak


Major Adverse Events to 30 Days Event

Result (N=12)

Total Patients with â&#x2030;Ľ1 MAE

1

Death

0

Bowel Ischemia

0

Myocardial Infarction

0

Paraplegia

0

Results shown as mean (range) or median

Renal Failure

0

Respiratory Complication

0

Stroke

0

Procedural Blood Loss â&#x2030;Ľ1000mL

1


Summary of Results to 30 Days  No Aneurysm Rupture  No Conversion to Open Repair  No Device Migration  No Stent Fracture or Graft Failure  No Type I or III Endoleak  No Renal Dysfunction  1 Mild Type II Endoleak  1 EIA/Device Limb Kink/Occlusion


Case #1 InfraSMA neck length = 30mm InfraSMA neck diameter = 26mm

Preoperative

1 Month


Case #2 InfraSMA neck length = 32mm InfraSMA neck diameter= 24mm

Preoperative

1 Month


Case #3 InfraSMA neck length = 15mm InfraSMA neck diameter = 21mm

Preoperative

1 Month


Case #4 Preoperative

InfraSMA neck length= 34mm InfraSMA neck diameter = 23mm


Case #5 InfraSMA neck length = 11mm InfraSMA neck diameter = 27mm

Preoperative

1 Month


Case #6 Preoperative

InfraSMA neck length = 19mm InfraSMA neck diameter = 25mm

1 Month


Case #7 Preoperative

InfraSMA neck length = 18mm InfraSMA neck diameter = 23mm

1 Month


Case #8 InfraSMA neck length = 43mm InfraSMA neck diameter = 23mm


Case #9 InfraSMA neck length = 8.3mm InfraSMA neck diameter = 23mm


Case #10 InfraSMA neck length = 44mm InfraSMA neck diameter = 25mm


Case #11 InfraSMA neck length = 15mm InfraSMA neck diameter = 21mm


Case #12 InfraSMA neck length = 33mm InfraSMA neck diameter = 26mm


Ventana™ Device Models Overview Intended Vessel Diameter

SMA to Aortoiliac Bifurcation Length

18-22mm

Model to be Selected Based on the Relative Location of the Renal Arteries Aligned (±15mm)

Right Proximal (>15mm to 30mm)

Left Proximal (>15mm to 30 mm)

≥110mm

F24-28/C100-S40A

F24-28/C100-S40R

F24-28/C100-S40L

22-26mm

≥110mm

F28-28/C100-S40A

F28-28/C100-S40R

F28-28/C100-S40L

26-30mm

≥110mm

F32-28/C100-S40A

F32-28/C100-S40R

F32-28/C100-S40L

30-34mm

≥110mm

F36-28/C100-S40A

F36-28/C100-S40R

F36-28/C100-S40L

Two models used to treat 12 patients


Summary  Ventana™ Proof of Concept Demonstrated  Off-the-Shelf Endovascular Repair of Juxtarenal and Certain Pararenal Aneurysms is Feasible

 Initial Early Outcomes are Encouraging  Feasibility Study Expansion Underway


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