1. Technical Presentation – Amy Dendulk

2. 14 Fr Unable to Pass 23 Fr 2 Year Aging 23 Fr New Valve Design
Main Projects:
14 Fr Unable to Pass
23 Fr 2 Year Aging
23 Fr New Valve Design

3. 14 Fr Introducer – Unable to Pass Overview of Issue
Design Requires 14Fr Tip to expand to accommodate CP
16 SPRs due to unable to pass tip Dec-Apr
Unable to Pass SPRs
Flow Back Length (mm)
Unable to pass tip

4. Insertion/Removal Force
Purpose
Evaluate insertion/removal forces of Impella CP through distal tip of sheath
Verification Test
No changes to current setup
Water at 37°C
Impella device (Large OD)
Additional Testing
Water replaced with porcine blood at 37°C
3 insertions/removals – Multiple Insertions increases force
Evaluated w/ introducers at varying conditions (MDX, Silicone Oil, FB Length)
Impella device
Pin with formed cannula, to set dimensions

5. Step Height Insertion Evaluation
Purpose
Use silicone media to compare sheath tip (step transition) insertion forces of current and new tip profile.
No link to clinical application
Used for comparison to current design only
Test Description
Dilator and dilator/sheath combination inserted into silicone substrate using Instron machine.
Measure force of silicone media to “overcome” tip step.
ID of silicone media varied
Force Profile Example
Insertion Force (N)
Insertion Distance (mm)
Dilator
Tip
Body
Sheath
Dilator Tip
Dilator body

6. Impella CP Dispensed Cannula OD
113 Impella CPs w/ dispensed cannula
Measured w/ Keyence
Maximum OD measured on cannula at inlet + motor transitions
Impella CP – Keyence
Parts that failed 5.05 ring gauge
Current 14Fr Spec. [BACK]

7. Proposed Design – Tip ID
Proposed tip ID would reduce interference w/ CP OD
Maintain single tipping mandrel at Oscor Inc to control spread of tip ID
To increase the tip ID, taper length reduced
(10-13% or 0.017” “)
Proposed Tip Spec
Current Tip ID Spec
Current Tip ID Spec
n=113 Cannula Max OD (CP)
Theoretical spread w/ single mandrel

8. C-66 (C1-08222) – Horizontal Method

9. A-1 (C1-08224) – Horizontal Method

10. 23 Fr 2 Year Aging (29 Samples)
Testing done:
Leak
Insertion/Removal Forces
Sheath Kink
Sidearm Flush Force
Reports Written:
-Sheath Kink
-Sidearm Flush Force

11. Sheath Kink Test Status: Pass
Acceptance Criteria: Sheath must pass through the 50° insertion angle with a radius of 7.1cm without forming an obstructive kink after dilator is removed.
Average (cm)
StDev (cm)
Min (cm)
Max (cm)
Insertion radius
3.49
0.82
2.0
4.5
Status: Pass

12. Hub Sidearm Flush Force Test
Acceptance Criteria: Maximum force required to flush 8 ml of saline through sidearm must be no more than 12N.
Average (N)
StDev (N)
Min (N)
Max (N)
Flush Force
9.68
0.93
7.86
11.44
Status: Pass

13. RP Pump Insertion/Removal Test
Condition
Average (N)
StDev (N)
Min (N)
Max (N)
Insert dilator
11.4
3.4
4.4
19.2
Remove dilator
12.3
2.0
7.0
17.0
Remove 6Fr diagnostic catheter
1.5
0.9
0.5
5.0
Insert pump through valve/hub
13.9
5.2
7.6
23.8
Insert pump through sheath
1.0
1.7
5.3
Remove guidewire
3.1
0.6
10.7
Remove pump
2.5
7.1
20.8

14. RP Pump Insertion/Removal Test
Condition
Rationale
Remove 6Fr diagnostic catheter
DIR to be updated to 5.0N to be consistent with CP and 2.5 platforms
Insert pump through valve/hub
2 sample t-test: p-value = 0.389
Remove guidewire
Remove pump
N/A per the IFU; sheath peeled away before removal

15. Valve Short-Term Leak Test
Condition
Average (g)
StDev (g)
Min (g)
Max (g)
Nothing across valve
0.0
Dilator in valve
Dilator removed
6Fr Diagnostic Catheter
8.3
15.6
66.4
0.025” Placement GW
0.4
1.5
8.2
Pump inserted
6.1
2.6
3.6
18.1
RP Pump & 0.025” GW
9.5
16.5
0.1
68.1
Pump Catheter
2.5
3.9
13.3
Total Leakage
26.8
34.7
4.3
145.3

16. Valve Short-Term Leak Test
Two-sample t-test performed comparing each step to data from T=0 verification testing
Condition
P-Value
Statistical Difference?
6Fr Diagnostic Catheter
0.537 No
0.025” Placement GW
0.446
RP Pump & 0.025” GW
0.466
Pump Catheter
0.307

17. Axillary Implant Kit – New Valve Design

18. Helix Valve (Variations)
Valve Options
Current 14Fr/23Fr Valve
Current 14Fr/23Fr Valve
2 Stacked Valves
Thickness: 0.060” each (1.52mm)
Opposing slits (horizontal/vertical)
Helix Valve
Single Valve
Thickness: 0.120” (3.05mm)
Helix center cut, with two peel-away cuts on outside
Primary Valve Functions for Axillary
Hemostasis – Prevent blood leakage during insertion procedure
Allow for easy pump insertion (insertion/removal force)
Helix Valve (Variations)
Variation in helix width

19. Proposed Leakage Requirement
Valve Leakage
Test Setup
Test Media: Water
Test Temperature: 37°C Test Pressure: 180 ±10 mmHg
Test Steps
Step
Leak Condition
Proposed Leakage Requirement
14Fr Requirement 1
Nothing in valve
Should be < 2.5g in 1 min
Must be < 2.5g in 1 min 4
6Fr Diagnostic Catheter in Valve
Should be < 25g in 3 min
Should be < 15g in 3 min 5
0.018" Guidewire in Valve
Should be < 10g in 1 min
Must be < 5g in 1 min 6
9Fr and 0.018" GW in Valve
Should be < 30g in 3 min 7
9Fr in Valve
Should be < 5g in 1 min 8
Nothing in Valve (pump removed)
Total
75g
42.5g
Proposed Requirement
Total 200mL volume of blood loss during Axillary Implant procedure (per IFU) including:
Leakage from introducer valve
Leakage through pump during insertion (when graft clamped)
Leakage from graft/sheath connection

20. Valve Leakage (nominal)
Leakage volume per minute should requirement
Blood Density- 1.06g/mL
Sample Size – 4 / group

21. Valve Leakage (extreme)
Leakage volume per minute should requirement
Blood Density- 1.06g/mL
Sample Size – 4 / group
SETUP

22. Valve Leakage (Extreme Test Setup)

23. Insertion/Removal Testing
Test Setup
Test Media: Water
Test Temperature: 37°C
Silicone Oil: MED400 1 drop (0.01mL)
Speed: 120in/min
Insertion Test Steps
Proposed Requirement
Insertion force of the Impella 5.0 through hemostasis valve must be less than 20N, should be less than 15N.
Insertion force of the Impella 5.0 through sheath and graft must be less than 10N.
MED-400 Application to Helix
Step
Pump Section 1
Pigtail (1.5”) 2
Inlet (1”) 3
Cannula (0.75”) 4 5
Pump Housing (1”) 6
Motor Housing (1”) 7
Catheter (1”)
Pigtail
Inlet
Cannula
Cannula
Pump Housing
Motor Housing
Catheter

24. Insertion/Removal Testing
20N Must
15N Should
Sample Size
Helix – 4 (each)
Current - 6

25. Insertion/Removal Testing
20N Must
15N Should
Sample Size
Helix – 4 (each)
Current - 8

26. S.E.M. Work

27. Lumen Stem
50x
100x

28. Pigtail Loop
50x
100x

29. The End!