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

2. Disclosures Abbott Vascular - Consultant
Boston Scientific - Consultant
Direct Flow Medical - Consultant
UC Davis

3. Introduction
Feasibility, safety, and efficacy of TAVR with Edwards-Sapien and Medtronic CoreValve have been well demonstrated
Large Effective Orifice Area
Durability
Securement
No coronary obstruction
Multiple sizes
Delivery profile
Opportunities for improvement
Reduction of paravalvular insufficiency
Improved access
Profile, flexibilty and trackability
Assess function before final deployment
Precise positioning
Repositioning
Retrievable
UC Davis

4. Direct Flow Medical Percutaneous Aortic Valve
Design Features
Bovine Pericardium Leaflets (anti-calcification treatment)
Balloon Frame covered with Polyester Fabric
Initial deployment - inflate frame with Saline/Contrast
When acceptable final position and function are confirmed, Polymer media is infused to replace saline/contrast
18 French deliviery system
Valve sizes - 25 mm, 27 mm treats annulus diameter mm
3 check valves
Valve is immediately functional when unsheathed and distal ring is inflated
UC Davis

5. Direct Flow Medical Percutaneous Aortic Valve
Design Features
Delivery System
Polymer nylon sleeve
Multi-lumen catheter
3 position and fill wires
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
UC Davis

6. Direct Flow Medical Percutaneous Aortic Valve
Valve loaded in Delivery System
Valve Unsheathed
Valve Inflated & Steering System
Valve in Retrieval Basket
UC Davis

7. Inflation, Deflation & Media Exchange
UC Davis

8. Positioning & Securement
UC Davis

9. Deliverability & Sealing
UC Davis

10. Complex Valve and Vascular Anatomy
87 year old male
Euroscore = 36.2
Moderately Calcified Leaflets &Native Annulus
Extensive Calcification
Marked Tortuosity
6 Month CT
Current Status:
52 Months
Post-Procedure
Final Position
UC Davis

11. Tracking - Aortic Arch
Deliverable and precisely positionable in any arch configuration including Horizontal Arch
UC Davis

12. Case Review: 009-01-003 (Cali) Access Summary No Complications
UC Davis

13. Balloon Aortic Valvuloplasty
UC Davis

14. Annulus and Procedure Results
Systole
Symmetric Calcium Score 1051
Diastole
UC Davis

15. Case Summary
UC Davis

16. Echo
Pre Procedure
Post TAVR Procedure
UC Davis

17. Important Feature
No significant paravalvular leak - aortic insufficiency
UC Davis

18. Important Feature
No significant paravalvular leak - aortic insufficiency
UC Davis

19. Important Feature Important Feature
No significant paravalvular leak - aortic insufficiency
UC Davis

20. Important Feature
No significant paravalvular leak - aortic insufficiency
UC Davis

21. Important Feature
No significant paravalvular leak - aortic insufficiency
UC Davis

22. 22 French Early Experience
University Medical Center, Hamburg-Eppendorf (n=25)
Helios Heart Center - Siegburg (n=6)
High risk patients for cardiac surgery
Patients Enrollment
Number / 22 Implants / 2 Surgical Conversions
Age ± 4 years
Female/Male /15
NYHA III – IV %
Logistic EuroSCORE ± 7%
Mean transvalvular gradient ± 14 mmHg
Aortic valve area ± 0.13 cm2
LVEF ± 15%
UC Davis

23. 22 French Early Experience 2 Year Data
Effective orifice area cm2
Mean Echo gradient
Functional Class I (75%) or II
Aortic insufficiency - 73% none & 27% minimal
2 year survival %
CT - No change in position, diameter and orifice area over time
Echo - Gradient 50.1±11.3 to 19.6±5.7 at 30 days - No change over time
AVA - Baseline 0.57±0.15 cm2 to 1.47±0.35 cm2 at 30 days - No change over time
UC Davis
Bujuklic K et al. Circ Cardiovasc Interv Dec 1;4(6):

24. Present Studies
Latest iteration (18 Fr) improved profile, positioning, valve loading into delivery sheath, radial force, valve competence, & simplified media exchange
IP South America - Colombia Study
IP European CE March Trial
France, Germany, Italy
UC Davis

25. Summary Direct Flow Medical Percutaneous Aortic Valve
Non-metallic fabric covered balloon supported bovine pericardial valve with excellent trackability and deliverability
Precise positioning, repositionable and retrievable
Mechanical securement with conformability and sealing to minimize paravalvular leak
Formed in-situ with exchange polymer media
Design permits functional and hemodynamic assessment before final deployment
Feasibility, safety and efficacy demonstrated with 22 F system European study with longest implant of 4.3 years
CE Mark and South American (Colombia) trial enrolling
No or trace paravalvular leak & no screening failures for peripheral access
UC Davis

26. University of California Davis Medical Center
Thank You
University of California Davis Medical Center

28. UC Davis