Technical Presentation – Amy Dendulk

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

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

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

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

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]

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” - .022“) Proposed Tip Spec Current Tip ID Spec Current Tip ID Spec n=113 Cannula Max OD (CP) Theoretical spread w/ single mandrel

C-66 (C1-08222) – Horizontal Method

A-1 (C1-08224) – Horizontal Method

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

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

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

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

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

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

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

Axillary Implant Kit – New Valve Design

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

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

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

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

Valve Leakage (Extreme Test Setup)

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

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

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

S.E.M. Work

Lumen Stem 50x 100x

Pigtail Loop 50x 100x

The End!