1. Direct Flow Medical
Experience with a Conformable, Repositionable, Retrievable, Percutaneous Aortic Valve
Reginald Low MD
University of California,Davis

2. Disclosure
Direct Flow Medical - Consultant

3. MEDTRONIC (CoreValve)
EDWARDS (Sapien)
MEDTRONIC (CoreValve)
DIRECT
FLOW
MEDICAL

4. Desireable Features - Percutaneous Aortic Valve
Function
Large Effective Orifice Area (EOA)
Durable - >10 years
Excellent Securement
Good apposition (No paravalvular leak)
No coronary obstruction
Multiple sizes
Deliverability
Low profile - 18 French or smaller
Flexible and trackable
Precise positioning
Repositionable
Retriveable
Direct Flow Medical Percutaneous Aortic Valve

5. Direct Flow Medical - PAV
Design Features
Leaflets - Bovine Pericardium (anti-calcification therapy)
Surgical Valve Design - Stentless
Balloon supported Polyester Fabric Cuff
Initial deployment with saline/contrast inflation
When final position and function is confirmed, saline/contrast replaced with water soluble polymer media under constant pressure in-situ
First generation - 22 French
Present generation - 18 French
Sizes 23mm, 25mm, 27mm
3 one way check valves
3 positioning-fill lumen
Immediately functional when unsheathed and distal ring is inflated
Check Valves
Position Fill Lumens

6. Direct Flow Medical - PAV
Design Features
Delivery System
Polymer nylon sleeve
Multilumen catheter
3 position and fill lumen
1 guide wire lumen
Flexible nose cone
Non-metallic delivery system and valve
Flexible and trackable
Precise positioning
Retrievable with deflation and withdrawl into retrieval basket
Position & Fill Lumens
Aortic Ring
Ventricular Ring
Guidewire Lumen

7. Direct Flow Medical - PAV
Valve loaded in Delivery System
Valve Unsheathed
Valve Inflated & Steering System
Valve in Retrieval Basket

8. Direct Flow Medical - PAV Positioning, Securement, Sealing

9. Direct Flow Animation 8

10. Direct Flow Retrieval

11. European Safety & Feasibility Study 22F System
University Medical Center, Hamburg-Eppendorf (n=25)
Helios Heart Center - Siegburg (n=6)
High risk patients for cardiac surgery
Patients Enrollment
Number 31 / 22 Implants / 2 Surgical Conversions
Age 82 ± 4 years
Female/Male 16/15
NYHA III – IV 71%
Logistic EuroSCORE 29 ± 7%
Mean transvalvular gradient 49 ± 14 mmHg
Aortic valve area 0.54 ± 0.13 cm2
LVEF ± 15
Investigational device not for sale in or outside the United States

12. Difficult Peripheral & Aortic Anatomy
87 year old male
Euroscore = 36.2
Moderately Calcified Native Annulus
Extensive Calcification
Marked Tortuosity
6 Month CT
Pt # HF
Current Status:
20 Months
Post-Procedure
Final Position
Investigational device not for sale in or outside the United States 11

13. Deliverability Flexibility, Trackability, Profile
Pt # UN
22F Direct Flow Medical 1

14. Difficult Valve Anatomy
Final Position
79 year old female
Euroscore = 20.3
6 Month CT
Pt # MN
Extensive Calcification
15 Month CT
Current Status:
23 Months Post-Procedure
Investigational device not for sale in or outside the United States 1

15. Sealing Minimizes Paravalvular Insufficiency
Pt # UN
Conformable cuff design – improves sealing 1

16. 1 Year Data (22 French)

17. 1 Year Data (22 French) As measured by TTE
Investigational device not for sale in or outside the United States

18. First Patient Treated MPG = 10 mmHg EOA = 1.98 cm² NYHA Class I
81 year old male
EuroSCORE = 25.8
Current Status:
2 Year Visit Complete
MPG = 10 mmHg
EOA = 1.98 cm²
NYHA Class I
Screening rs
Final Positioning
Post Op CT
Investigational device not for sale in or outside the United States 1

19. Extended Follow Up Follow-up 12 to 24 Months
In all patients, no significant changes :
Mean/peak gradients
Effective orifice area
Aortic regurgitation, paravalvular leaks
LVEF
NYHA functional class
Investigational device not for sale in or outside the United States

20. Latest Generation 18 French
Profile Reduction
22 F
18 F
Increased Radial Force
Improved Positioning
Simplified Valve Retrieval
Improved Valve Loading
Atraumatic
Tip
Investigational device not for sale in or outside the United States 1

21. Summary Direct Flow Medical PAV
Non-metallic fabric covered balloon supported bovine pericardial valve
Repositionable and retrievable
Mechanical securement with conformability and sealing
Formed in-situ with exchange polymer media
Design permits functional and hemodynamic assessment before final deployment
Next generation 18 French improves profile, positioning, valve loading into delivery sheath, radial force
Feasibility, safety and efficacy demonstrated with 22 F system European study with longest implant of 2.4 years
Final design validation and testing for next generation 18 French in progress before European Trial in Q4 2010