1. Portico™ Transcatheter Aortic Valve Replacement Program CRT 2013
Hasan Jilaihawi, M.D.
Raj R. Makkar, M.D.
Cedars-Sinai Heart Institute
Los Angeles, CA

2. Hasan Jilaihawi, MD, MRCP
Consulting: Edwards Lifesciences, LLC, St. Jude Medical, Inc., Venus Medtech
Off-Label: Discussion pertaining to transcatheter valve therapies

3. Portico Design Features
Stent retainer tabs
Leaflet commissure attachments
Bovine pericardial leaflets
Porcine pericardial skirt
Inflow cut-outs
Rounded inflow edges
Outflow view

4. Portico Valve Design Features
Both leaflets and cuff are treated with LinxTM AC treatment*
Same anticalcification technology used on Epic and Trifecta surgical valves
Nonflared annulus section of the stent
Portico
23 mm Valve
*There is no clinical data currently available that evaluates the long-term impact of anticalcification tissue treatment in humans.

5. Annulus sizes treated (mm)
SJM Portico TAVI
Valve size
(mm)
Annulus sizes treated (mm)
Aortic diameter
Height 23
19 – 21 41 50 25
21 – 23 43 52
Valve sizes 27 & 29 mm are in development and will be added to the IDE H2 2013

6. SJM Portico Design – Comparison
Sapien /
Sapien XT
CoreValve
Portico
Technology
Balloon expandable
Self-expanding
Placement
Intra-annular
Supra-annular
Stent
Stainless steel/ CoCr
Nitinol
Stent geometry
Scaffold
Diamond cell
High density
Low density
Valve sizes
20 / 23 / 26 / 29
23 / 26 / 29 / 31
23 / 25 / 27 / 29
Leaflet tissue type
Bovine
Porcine
Transfemoral delivery system
18 /19 / 22 / 24 Fr
18 Fr
Transapical delivery system
26 Fr
Requires sheath
N/A
24 Fr
(Sheathless)

7. SJM Portico Design – Comparison
Stent retainers
(2) High profile
(3) Low profile
Cell Density- aortic
9X2
15X4
stent integrated
cell/tissue
Commissures
Waist V e r t i c a l T p d
Vertical versus taper may facilitate annular sealing to minimize PV leak
Cell Density- annulus
9X2
15X5
Medtronic CoreValve
SJM Portico

8. Stent Design: Large Cell Geometry
Large stent cells in the aortic section of the stent, allows access to coronary ostia post-implant
Aortic
Section
Annulus
Section
Manoharan, G., St. Jude Medical Portico™ Transcatheter Aortic Valve Clinical Experience, EuroPCR, 05/17/2012.

9. Stent Design: Large Cell Geometry
Large stent cells within annulus section of the stent
Less metal
Minimizes risk of stent strut resting against a calcific nodule
More tissue
Allows for tissue to conform around calcific nodules
Calcific nodules

10. Calcific Nodule Simulation
Three randomly placed nodules simulate calcification within the native aortic annulus
Large cell geometry allows cuff tissue to conform around calcific nodules
Calcific Nodules
Potential area for PV Leak jet
Speakers Notes:
* This is bench testing data where three randomly placed nodules simulate calcification within the native aortic annulus.
* The large cell design in the annulus section of the Portico stent allows the cuff tissue to conform around calcific nodules, minimizing the risk of PV leak.
Note: Irregular “D” shape of stent
Calcific Nodules
Portico
CoreValve

11. Portico: Intra-annular Placement
Conformable stent frame adapts to anatomical variations and annulus calcification
Leaflet geometry designed to optimally function in both round and ellipse configurations
Leaflets function at partial deployment allowing for a gradual, controlled deployment while avoiding hemodynamic instability
MDCT 3-dimensional reconstruction of Portico valve
Speakes Notes;
Portico’s conformable stent frame adapts to anatomical variations
The leaflet geometry is designed to function in both round and ellipse configurations
The leaflets function at partial deployment allowing for gradual, controlled deployment wile avoiding hemodynamic instability
Stent eccentricity at (C) inflow level, (D) valvular level and (E) outflow level
Willson A, et al. Transcatheter aortic valve replacement with the St Jude Medical Portico. J. Am Coll Cardiol. 2012;60(7):

12. Portico™ Transcatheter Aortic Valve
Portico is designed for leaflet coaptation in round and elliptical annulus configurations
In-vitro testing over the valve’s use range, and in various annulus configurations to assess durability and hydrodynamic performance
Circular Configuration
Elliptical Configuration
The Portico system is not available for sale. 

13. Resheathing and Repositioning Feature
The unique valve and delivery system design of Portico allows the ability to fully resheath* the valve:
Reposition proximally or distally*, in situ
Retrieve* the valve, if necessary
Resheathability is designed to enable optimized valve positioning during implantation
*Until fully deployed
Speaker’s notes: It is not just the valve, or the delivery system design that allows for Portico’s resheathing feature. Design elements of both the valve and delivery system provide the ability for the valve to be completely resheathed within the delivery catheter.
Manoharan, G., St. Jude Medical Portico™ Transcatheter Aortic Valve Clinical Experience, EuroPCR, 05/17/2012.

14. Portico Valve Loading System
Loading Tools include:
Loading tube
Loading funnel
Loading base
Base insert
Leaflet tester
Preparation and valve loading performed at room temperature
Portico TF Loading Tools

15. Portico Transfemoral Delivery System
Compatible with 18 F introducer sheath
Designed for flexibility and trackability
Leaflet functionality after partial deployment, allowing controlled deployment to assess:
Valve placement
Repositioning*
Retrieval* of valve, if necessary
Fully Sheathed
Partially Unsheathed
Functioning leaflets during deployment
Majority Unsheathed
*Until fully deployed

16. Portico Transfemoral Delivery System
Distal End
Protective Sheath
Retainer Receptacle
Radiopaque Tip
Protective Sheath Marker
Inner Shaft
Inner Shaft Marker Band

17. Portico Transfemoral Delivery System
Control Handle Features
Deployment / Resheath Wheel — deploy clockwise
80% Release Lever
Sliding Mechanism Buttons — used during valve loading
Lumen Flush Port
Sheath Flush Port
Locking Buttons
Resheath — counterclockwise

18. Baseline Characteristics
Belfast FIH
Canadian FIH n 10 11
Age, yrs
85.8±2.7
82.9±5.7
Female
100%
NYHA class III (pre-TAVI) 7 8
STS score (mortality)
6.5±2.4
7.8±3.2
Logistic Euroscore
18.9±9.6 NA
Aortic valve area (cm2)
0.7±0.2
0.62±0.15
Mean gradient (mmHg)
40.7±12.6
46.2±17.5
Left ventricular ejection fraction
64.4±6.8
57.3±13.8

19. Procedural Information
Belfast FIH
Canadian FIH n 10 11
Anaesthesia
All under local anaesthesia
All under general anaesthesia
Procedure Time (mins)
54 ± 10.4 NA
Multiple valves in same patient 1
Valve resheathing 2 4
Depth of implant below NCC
5.65±1.15
6.4±1.0
New Left bundle branch block
New Permanent pacemaker

20. Clinical Safety Results
Belfast FIH
Canadian FIH n 10 11 5*
30D
1 yr
Death
Major stroke
New Pacemaker Implantation
Myocardial Infarction
Left Bundle Branch Block 3
Aortic regurgitation over mild
Minor vascular complication 1
* Total patients who have thus far met the 1 year follow up timeline
“Transcatheter Aortic Valve Replacement with the St. Jude Medical Portico Valve” Willson, et al, JACC Vol. 60, No. 7, 2012, August 14, 2012:581–6

21. Echo Data: Mean and Peak Gradients
Belfast FIH
Canada FIH
N=5
N=6
N=11
Changes observed from baseline to 30 days were sustained at the 12 mo follow-up

22. Aortic Regurgitation Belfast FIH Baseline 3 month 6 month 12 month
Canada FIH
n=11
n=11
n=6
n=5

23. Portico Transapical Delivery System
24 F outer diameter
Does not require an external sheath for apical access
Use of an external sheath results in a larger apex puncture site
Portico Transapical Delivery System
Single operator deployment / resheath wheel
Protective sheath covers the valve
Atraumatic, radiopaque tip

24. Portico Transapical Delivery System
Annulus-first deployment
Majority of stent can be unsheathed allowing leaflet functionality, to assess:
Valve placement
Repositioning
Retrieval of valve, if necessary
Functioning leaflets during deployment
Fully Sheathed
Partially Unsheathed
Majority Unsheathed
Transapical Portico over .035” wire
Portico transapical delivery system not commercially available.

25. Portico TA First-in-Human Case, November 15, 2012. Drs
Portico TA First-in-Human Case, November 15, Drs. Cheung and Webb, St Paul’s Hospital, Vancouver
73 yo Asian female
37 KG, 154 cm (82 lbs, 5’1”)
Severe Aortic Stenosis, Preserved LV Function
Prior CABG, patent grafts
Moderate MR
Failed TF, Sapien XT
Unable to pass valve through 14F eSheath
Vascular injury
Esophageal Injury
Recovered, considered for Transapical TAVR

26. Portico TA First-in-Human Case, November 15, 2012. Drs
Portico TA First-in-Human Case, November 15, Drs. Cheung and Webb, St Paul’s Hospital, Vancouver

27. Portico Transapical FIH
Extubated early post operatively Discharged POD 4 Pre-Discharge TTE Trace PVL Mean Gradient 10 mmHg Doing well 3 weeks later

28. Proposed Trial Design Multi-Cohort Study High Risk Extreme Risk
Valve-in-Valve
Registry
Access
(≥ 7-8 mm femoral access)
Assess A-TAVR* TF Access
( ≥7-8 mm femoral access)
Yes No
Yes No
1:1 Randomization
Non-inferiority TF
A-TAVR*
TF Portico
6 mm to < 7-8 mm applicable to femoral access
TA Portico TA
A-TAVR*
1:1 Randomization
Non-inferiority
Yes No
1:1 Randomization
Non-inferiority
Portico TF
Registry
Portico TA
Registry
TF Portico TF
A-TAVR*
*A-TAVR: Approved TAVR valve 28
CONFIDENTIAL

29. Portico Program Status
23mm TF: CE Mark approved 23mm TA: FIH series completed 25mm TF: Enrollment in EU clinical trial underway 27/29mm: EU clinical trial enrollment 1H 2014 US IDE: Submitted Q US clinical trial to commence in 2H 2013

30. Thank You