Clinical Dossier

Question 1

When did impella 2.5 receive its PMA approval from the US FDA?

Answer 1

March 23rd, 2015

Question 2

When did impella CP receive PMA approval from the US FDA for the indication of Protected PCI?

Answer 2

December 2nd, 2016

Question 3

When did the Impella 2.5 and CP receive an expanded PMA approval for high-risk PCU with or without depressed EF?

Answer 3

February 14th, 2018

Question 4

True or False: The Impella Heart Pumps are the only percutaneous temporary ventricular support devices that are FDA approved as safe and effective for High Risk PCI

Answer 4

True

Question 5

List 7 examples of comorbidites

Answer 5

1. Surgical Ineligibility
2. Prior Cardiac Surgery
3. Heart Failure
4. Diabetes
5. Advanced Age
6. Unstable Anina/NSTEMI
7. Renal Insufficiency

Question 6

The clinical data demonstrating the Impella heart pumps safety and effictiveness includes > ______ Patients from an FDA- randomized, controlled trial and what?

Answer 6

1600

FDA-audited, IRB approved, multi-center registry

Question 7

Over 200 ____ ____ _____ in the high risk PCI settings demonstrate safety and efficacy

Answer 7

Peer-reviewed publications

Question 8

Impella 2.5 and CP maintain patient hemodynamics during planned temporary coronary occlusion by doing what?

Answer 8

Maintaining MAP, which may allow for a more through procedure and a more complete revasculariztion in a single session

Question 9

Use of Impella device is associated with reduction of kidney injury during a:

Answer 9

High Risk PCI procedure

Question 10

There is a 6x increased risk in _______ without the impella device

Answer 10

Dialysis

Question 11

Clincial outcomes of the Protect II randomized controlled trial demonstrated a ________ % reduction in MACCE at 90 days

Answer 11

29%

Question 12

______ ______ was also associated with the largest reduction of adverse events.

Answer 12

Extensive Revascularization

Question 13

At 90 days, there is a _______ % reduction in repeat revascularization

Answer 13

52% (0.024)

Question 14

At 90 days, there was a _______ % recused length of stay in hospital.

Answer 14

22%

Question 15

At 90 days, there was a ____ % reduction in NYHA class of heart failure

Answer 15

58%

Question 16

______ _____ is critical high-risk procedures are usually longer and use higher levels of contrasts, chronic kidney disease is a common comorbitity.

Answer 16

Kidney protection

Question 17

A retrospective study showed incidence of all AKI was ____ % without Impella compared to ____ % with impella.

Answer 17

27. 8%

5. 2%.

Question 18

Study observation included what?

Answer 18

Few readmissions, less days in the hospital, and a better quality of life through reduced heart failure symptom after a protected PCI procedure

Question 19

The impella 2.5 and CP directly unload the LV and propels blood forward, from the left ventricle into the aorta, in a ___________.

Answer 19

Manner consistent with normal physiology.

Question 20

Impella heart pumps provide both _____ forward flow and _____ aortic pressure contribution.

Answer 20

Active

Systemic

Question 21

Active forward flow and systemic aortic pressure contribution leads to an efficiency increase in ____ and overal _____

Answer 21

MAP

CPO.

Question 22

Combined with LV unloading, Impella support reduces what and augments what?, leading to favorable alteration of the balance of myocardial oxygen supply and demand.

Answer 22

EDV & EDP

Peak coronary flow

Question 23

When was Impella commercially used under a 510K clearance?

Answer 23

2008

Question 24

Where is the device approved?

Answer 24

Europe 2004
Canada 2007
Latin and South America 2008-2012
China 2013
India 2017
Japan 2016

Question 25

In the US, the device has been used since _____, beginning with the Protect 1 FDA approved trial for thigh risk PCI

Answer 25

2006

Question 26

How many peer reviewed publications has impella been investigated in, making it the most studied circulatory support device on the market ?

Answer 26

400

Question 27

In 2011, ACC/AHA/SCAI PCI guidelines considered the house of hemodynamic support devices as “an adjunct to PCI to be reasonable in carefully selected high - risk patients” as a category

Answer 27

IIB )i.e., benefit > or equal to risk for high risk PCI

Question 28

How many patients have been studied support the PMA indication of impella 2.5 and CP in protected PCI ?

Answer 28

2,403

Question 29

List 5 scientific evidence sources to support PMA Applications

Answer 29

``` Protect 1 Protect 2 US Impella Registry Literature Review CVAD registry ```

Question 30

What was Protect 1?

Answer 30

Prospective, single arm, multi-center feasibility study designed under FDA guidance to examine the safety and feasibility of the Impella device in patients undergoing high-risk angioplasty.

Question 31

Who could enroll?

Answer 31

Patients with an LVEF <35% and undergoing PCI to LM or last patent conduit.

Question 32

What was protect II?

Answer 32

Prospective, multi-center randomized trial comparing outcomes between impella 2.5 and IABP in patients that required hemodynamic support during elective or ugentent high risk procedures

Question 33

Beyond the goal of establish a reasonable asssurance for safety and effectiveness, the objective of the study was to do what?

Answer 33

Demonstrate that prophylactics use of Impella 2.5 is superior to the IABP in preventing peri and post procedural major adverse events (MAE) in this patient population.

Question 34

How many people the Protect II trial enroll and how many sites?

Answer 34

452 at 112 sites

Question 35

What was the primary efficacy endpoint?

Answer 35

Composite MAE at 30 days with follow up analysis at 90 days

Question 36

Who was enrolled in protect II?

Answer 36

High risk PCI on an unprotected LM or last patent conduit, with an LVEF <35% or patients who had 3 vessel disease and an LVEF < 30%. O

Question 37

Operators identified target lesions and aimed for the most complete revasculature prior to what?

Answer 37

Randomization

Question 38

What was the average STS score?

Answer 38

6 +- 6 %

Question 39

What was the average EF?

Answer 39

24 +- 6

Question 40

What percentage of patients in Protect II had prior CABG?

Answer 40

34%

Question 41

Patients discharged from the cath lab supported by a device was lower in Impella group compared to the IABP group.

Answer 41

Impella: 5.9 % IABP: 36.7%

Question 42

What was the composite MAE event at 90 days for IABP?

Answer 42

51%

Question 43

What was the composite MAE event at 90 days for Impella?

Answer 43

40% p value = 0.023

Question 44

In 2010, the composite 90 dat MAE event rate of IABP vs Impella was what? And Why

Answer 44

Learning Curve: 36.8% vs 50.8% p = 0.104. Learning curve

Question 45

______ the amount of atherectomy was used in the Impella arm vs IABP

Answer 45

Twice

Question 46

What percent of the population received athetherectomy ?

Answer 46

12%

Question 47

Less repeat revasc procedures were observed in the Impella arm compared to the IABP at 90 days.

Answer 47

IABP: 30.8% Impella: 4%

Question 48

What percent of the population did not receive atherectomy?

Answer 48

88%

Question 49

What were the MAE rates for both arms at 90 days in the group that did not receive atherectomy?

Answer 49

IABP: 50.5% Impella 35.5 % P value = 0.003

Question 50

What percent of the population had 3 vessels disease?

Answer 50

76%

Question 51

What was the composite MAE rates for both arms at 90 days in Patients with 3-vessel disease?

Answer 51

IABP:51% Impella: 39% P valued = 0.039

Question 52

What percent of the population had an STS score <10%?

Answer 52

83%

Question 53

What was the composite MAE at 90 days for patients with STS <10?

Answer 53

IABP: 50.6% Impella 36.1% P values = 0.006

Question 54

Why was an 8x ULN threshold for CKMB bump used In a post hoc analysis by DANGAS?

Answer 54

To reflect a contemporary and prognostically relevant definition of MI.

Question 55

In the Post Hoc Analysis DANGAS, ___ rates were observed

Answer 55

MACCE

Question 56

In the DANGAS, post hoc anaysis, what were the composite primary endpoint MACCE rates at 90 days for IABP vs Impella?

Answer 56

IABP: 31% Impella: 22% P value- 0.033

Question 57

Post-hoc analysis of the composite MACCE rates using a meaningful, contemporary definition of peri-procedural MI 8x ULN showed what?

Answer 57

P=0.042 | Decrease MACCE rates at 90 days.