1. Progress with the Sadra Medical Lotus™ Valve System
CRT 2011
Washington DC, February 27th – March 1st
Progress with the Sadra Medical Lotus™ Valve System
Eberhard Grube, MD, FACC, FSCAI
University Hospital, Dept of Medicine II, Bonn, Germany
Hospital Alemaõ Oswaldo Cruz, Saõ Paulo, Brazil
Stanford University, School of Medicine, Palo Alto, CA

2. Eberhard Grube, MD
Within the past 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Physician Name Company/Relationship
Eberhard Grube, MD Medtronic, CoreValve: C, SB, AB, OF
Sadra Medical: E, C, SB, AB
Direct Flow: C, SB, AB
Mitralign: AB, SB, E
Boston Scientific: C, SB, AB
Biosensors: E, SB, C, AB
Cordis: AB
Abbott Vascular: AB
Capella: SB, C, AB
Devax: SB, AB,
Embrella: SB
Claret: SB
Key
G – Grant and or Research Support E – Equity Interests S – Salary, AB – Advisory Board
C – Consulting fees, Honoraria R – Royalty Income I – Intellectual Property Rights
SB – Speaker’s Bureau O – Ownership OF – Other Financial Benefits‘

3. Sadra Lotus™ Valve Concept
Braided nitinol stent structure
Radial expansion as it shortens
Enables a more flexible delivery system
Enables device repositioning or retrieval
Provides significant radial strength
To be used exclusively for clinical investigations. Not for Sale or Use in the United States 3

4. Procedure Overview
To be used exclusively for clinical investigations. Not for Sale or Use in the United States 4

5. Advantages of the Lotus Valve System
Ease of Use
System is pre-packaged on delivery system
Two handle controls
1 - deploy / retrieve and 2 - release
Deploy
Retrieve
Release
To be used exclusively for clinical investigations. Not for Sale or Use in the United States 5

6. Advantages of the Lotus Valve System
Ease of Use
Controlled Positioning
Predictable, reversible deployment
Fully repositionable, both distally and proximally as needed
Retrievable at any point prior to release
Engineered or Designed (vs. envisioned to provide)
Retrievability vs. retrievable (since it follows the phrase,’ to provide:’ )
To be used exclusively for clinical investigations. Not for Sale or Use in the United States 6

7. Advantages of the Lotus Valve System
Ease of Use
Controlled Positioning
Accurate Placement
Center marker facilitates alignment with native valve
Valve leaflet function begins early during deployment
Hemodynamic stability
Enhances precision positioning
Center Marker
To be used exclusively for clinical investigations. Not for Sale or Use in the United States 7

8. Advantages of the Lotus Valve System
Ease of Use
Controlled Positioning
Accurate Placement
Minimal perivalvular leakage
Adaptive™ Seal fills gaps between native valve and implant
Adaptive Seal
To be used exclusively for clinical investigations. Not for Sale or Use in the United States 8

9. Advantages of the Lotus Valve System
Ease of Use
Controlled Positioning
Accurate Placement
Minimal perivalvular leakage
Percutaneous delivery
Proprietary Lotus Introducer Sheath provides access to ≥ 6.0mm femoral vessels - equivalent to Cook 18F introducer
To be used exclusively for clinical investigations. Not for Sale or Use in the United States 9

10. Case Study
83 y/o Female
History of CAD, CHF, Hypertension, high cholesterol and Lipidemia, Mitral and Tricuspid Valvular Disease
NYHA III
STS: 4.2 / Euroscore: 15.6
Echo/CT data pre-procedure:
Annulus size: 21mm by echo; mm by CT
AVA: 0.6 cm2
Mean Pressure Gradient: 60.2 mmHg
EF: 33%
To be used exclusively for clinical investigations. Not for Sale or Use in the United States 10

11. Valvuloplasty
To be used exclusively for clinical investigations. Not for Sale or Use in the United States 11

12. Delivery
To be used exclusively for clinical investigations. Not for Sale or Use in the United States 12

13. Unsheathing
To be used exclusively for clinical investigations. Not for Sale or Use in the United States 13

14. Repositioning
To be used exclusively for clinical investigations. Not for Sale or Use in the United States 14

15. Locking
To be used exclusively for clinical investigations. Not for Sale or Use in the United States 15

16. Pre-Release Assessment
To be used exclusively for clinical investigations. Not for Sale or Use in the United States 16

17. Release
To be used exclusively for clinical investigations. Not for Sale or Use in the United States 17

18. Final Result
To be used exclusively for clinical investigations. Not for Sale or Use in the United States 18

19. Post Procedure Clinical Outcome
TTE data post-procedure (one day after the procedure):
AVA: 1.5 cm2
Mean Pressure Gradient: 9 mmHg
AR: None
Time from introducer sheath insertion to removal:30 min.
Time from delivery catheter insertion to removal: 12 min. 19

20. Study Enrollment
12 patients have been enrolled at 3 sites, with 9 patients implanted with the Lotus™ Valve System
First patient enrolled: April 13, 2010 at Essen Elisabeth by Prof. Grube
Site # PI
Pts Enrolled
Pts Implanted
01 - Siegburg
Dr. R. Mueller 4
02 - Essen Elisabeth
Prof. E. Grube 2
03 - Essen University
Prof. R. Erbel 3
Total 12 9 20

21. Baseline Demographics
Characteristic
N=12 pts
Age, years
84±3.8
Gender, Female
100% (12/12)
History of Arrhythmia (including AF)
25% (3/12) AF
100% (3/3)
History of CHF
17% (2/12)
CAD or CID
67% (8/12)
History of Hypertension
Other Valve Disease
83% (10/12)
Peripheral Vascular Disease
42% (5/12)
NYHA Class III or IV
Euroscore (Logistic)
25%±9.6
STS
7%±5.9 21

22. Echo Data - Pre, Post & 30-Day Follow-up
* Site reported data 22

23. Clinical Results at 30 Day Follow-up Primary Endpoint Events
12 Patients Enrolled
extreme tortuosity associated with ectasia prevented implantation
procedural deaths with no valve implantation 3
9 Patients Implanted
Primary Endpoint Events
Implanted (n=9)
All Deaths 1
MI (ARC definition)
Stroke with permanent deficit
Re-intervention for Valve-related complications
Procedure Success 9
To be used exclusively for clinical investigations. Not for Sale or Use in the United States 23

24. Next Steps Preparing for multi-center OUS CE trial submission.
27mm valve achieved 200MM cycles in testing.
Initiating CE trial with both 23 and 27mm valves in 2011. 24