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Lutonix Flashcards

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1
Q

How many total subjects have been studied in the Lutonix 035 DCB clinical program?

A

3,157 subjects

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2
Q

What was the 12-month Kaplan-Meier relative primary patency improvement over PTA for the Lutonix 035 DCB in the LEVANT 2 IDE Trial?

A

At 12 months, Kaplan-Meier primary patency was 27.9% higher in the DCB arm relative to the PTA arm of LEVANT 2 (73.9% vs 57.8%)

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3
Q

What percent of patients treated with the Lutonix 035 DCB in the LEVANT 2 clincal trial received bailout stenting?

A

2.5%

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4
Q

What were the 5 optimal procedural techniques observed to positively influence primary patency in the LEVANT 2 trial?

A

Transit time to lesion < 30 seconds balloon
Pressure > 7atm
Balloon inflation time >= 120 seconds
Final residual stenosis < 20%
Balloon sizing >= 1:1 (full wall apposition)

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5
Q

What was the % increase over the LEVANT 2 12-month primary patency reate of 73.9% when 4 optimal procedural techniques were used?

A

17.8% increase

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6
Q

In the post-hoc LEVANT 2 subgroup analysis, what was the relative 12-month Kaplan-Meier primary patency improvement over POBA for patients who received full wall apposition?

A

65.8% improvement

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7
Q

What is POBA?

A

“Plain old balloon angioplasty”

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8
Q

The Lutonix 035 DCB had what rate of freedom from TLR at 24 months in long lesions in the Global SFA Registry?

A

88.2% freedom from TLR at 24 months in long lesions

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9
Q

The Lutonix 035 DCB had what rate of freedom from TLR at 24 months in in-stent restenosis in the Global SFA Registry?

A

84.6% freedom from TLR at 24 months in ISR lesions

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10
Q

What were the Kaplan-Meier primary patency % outcomes at 24 months for the Lutonix DCB and IN.PACT DCB in the Mori Study?

A

Lutonix 72%
IN.PACT 70%

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11
Q

What were the conclusions to the Steiner and Mori Studies?

A

That there was no statistical difference in clinical outcomes for patients receiving Lutonix DCB and IN.PACT DCB at 18 and 24 months

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12
Q

What is the shelf life for Lutonix?

A

24 months

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13
Q

In what month in 2014 was Lutonix 035 approved?

A

October 2014

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14
Q

In the LEVANT 2 IDE trial, what was the relative primary patency improvement from the DCB subgroup compared to the PTA subgroup?

A

27.9% improvement

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15
Q

In the Ranger II SFA trial, what was the relative primary patency improvement for the DCB subgroup compared to the PTA subgroup?

A

21.4% improvement

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16
Q

How many balloon sizes are available on the Lutonix™ DCB platform? (AV included)

A

66

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17
Q

What was the conclusion of the Mori study in Japan?

A

There was no statistical difference in clinical outcomes for patients receiving Lutonix™ DCB and IN.PACT™ DCB at 24 months

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18
Q

What is the longest balloon length offered on the IN.PACT™ 018 DCB platform?

A

150mm

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19
Q

What is the name of the RCT thatcompared clinical outcomes of the low-dose Ranger™ DCB and high-dose IN.PACT™ DCB out to 24 months and found that there was no statistically significant difference in clinical outcomes?

A

COMPARE RCT

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20
Q

Which one of the RCT listed belowcompared clinical outcomes between two drug coated balloons that are FDA-approved?

A

TRANSCEND PAD

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21
Q

In what year did the IN.PACT™ DCB recieve FDA approval?

A

2014

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22
Q

What was the conclusion of the COMPARE RCT

A

There was no statistical difference in clinical outcomes for patients receiving Ranger™ DCB and IN.PACT™ DCB at 24 months

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23
Q

True or False: The Ranger™ DCB is indicated to treat in-stent restenosis.

A

False

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24
Q

Where did the first commercial case for Lutonix™ DCB take place?

A

New York City

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25
How many balloon sizes are offered on the Ranger™ DCB platform?
29
26
What was one of the conclusions drawn from the TRANSCEND PAD IDE Trial?
There was no statistical difference in clinical outcomes for patients receiving SurVeil™ DCB and IN.PACT™ DCB at 24 months
27
What percent of patients treated with the IN.PACT™ DCB in the IN.PACT SFA Trial received bailout stenting?
7.3%
28
Which competitive DCB is the only other DCB to offer an in-stent restenosis indication?
IN.PACT™ DCB
29
How many total subjects have been studied in the SurVeil™ DCB clinical program?
235
30
What was the Kaplan-Meier primary patency rate in the PTA arm of the Ranger II SFA Trial at 12 months?
74%
31
The IN.PACT™ DCB had what rate of Kaplan-Meier freedom from clinically-driven TLR at 24 months in the IN.PACT Global Study?
83.3%
32
The Lutonix™ SFA Reintervention Free-Warranty Program is the only SFA DCB warranty program out to 24 months, what are the names of the other two warranty programs that are only offered out to 12 months?
Bold Step Program and Outcomes Protection Program
33
Where did the Steiner Study, which showed there was no statistical difference in clinical outcomes for patients receiving Lutonix™ DCB and IN.PACT™ DCB at 18 months, take place?
Germany
34
Which DCB has the highest freedom from TLR at 24 months?
Lutonix
35
How many different formulations were tested before the final formulation was chosen for Lutonix DCB™?
250
36
In a dry inflate shake test, the Lutonix™ 035 DCB showed what percentage of drug loss?
<0.1%
37
How many balloon sizes are available on the IN.PACT™ DCB platform? (AV included)
54
38
What is the human plasma half-life of the Lutonix™ DCB formulation?
6.88 hours
39
What is the longest balloon length offered on the SurVeil™ DCB platform?
150mm
40
The Stellarex™  DCB had what rate of freedom from TLR at 24 months  overall  in the Illumenate Global Study?
85.3%
41
The Lutonix™ 035 DCB had what rate of freedom from TLR at 24 months overall in the Global SFA Registry?
90.3%
42
What is the name of the study that compared clinical outcomes of the low-dose Lutonix™ DCB and high-dose IN.PACT™ DCB out to 24 months and found that there was no statistically significant difference in clinical outcomes?
LANDMARK Registry
43
Fill in the blank: In LEVANT 2, an estimated ____ out of ten patients treated with Lutonix™ 035 DCB did not require reintervention within a year.
9
44
In the SAFE-DCB U.S. Registry, what was the freedom from TLR at 36 months?
74.4%
45
In the Ranger All-Comers Registry, what was the freedom from TLR at 24 months?
66%
46
True or False: The Lutonix™ DCB was the first DCB to offer both 0.018" and 0.035" guidewire compatability
True
47
What is the largest french size for a balloon the Lutonix™ DCB SFA platform?
5F
48
In a dry inflate shake test, the Medtronic™ DCB showed what percentage of drug loss?
10%
49
How many balloon sizes are available on the Stellarex™ DCB platform?
21
50
What is the longest balloon length offered on the Stellarex™ DCB platform?
200mm
51
What percent of patients treated with the Ranger™ DCB in the Ranger II SFA Trial received bailout stenting?
5%
52
Fill in the blank: Lutonix™ DCB is the only DCB on the U.S. market long enough to treat lesions up to 290 mm in length with a single balloon. It can reduce DCB acquistion costs by around __% compared to other DCBs?
50%
53
What were the primary patency results for the SurVeil™ DCB at 24 months in the TRANSCEND PAD Trial?
70.8%
54
Fill in the blank: In the Global SFA Registry, an estimated ____ out of ten patients treated with Lutonix™ 035 DCB did not require reintervention within two years
9
55
Paclitaxel is a mitotic inhibitor designed for inhibiting cell proliferation/intimal hyperplasia. Is Paclitaxel cytostatic or cytotoxic?
Cytotoxic
56
The Medtronic Outcomes Protection program only goes out to 12 months and does not offer a free replacement DCB if a patient returns for reintervention within a year. What does the warranty program for IN.PACT™ DCB offer?
$1,000 rebate
57
In the Shammas study, what was the 5-year freedom from TLR for the Lutonix™ DCB-only cohort
78.5%
58
The IN.PACT™ DCB had what rate of Kaplan-Meier freedom from clinically-driven TLR at 60 months in the IN.PACT Global Study?
69.4%
59
The Lutonix™ SFA Reintervention-Free Warranty program was launched in 2021. Since its inception, how many warranty claims have been made?
3
60
There are over 3,100 patients in the Lutonix™ DCB Clinical Program- which is over 13x bigger than SurVeil™ DCB's clinical program. How many patients are in SurVeil™ DCB's clinical program?
235
61
The 12-month primary patency rate in LEVANT 2 was 73.9%. Using the four optimal procedural techniques listed below, what was the relative improvement in primary patency rate? -Transit time to lesion <30 seconds -Balloon Pressure >7 atm -Balloon inflation time >=120 seconds -Final residual stenosis <20%
17.8%
62
Fill in the blank: The Lutonix™ DCB has been used to treat over ___________ patients worldwide.
675,000
63
In the Lutonix Global SFA Registry, the Lutonix™ 035 DCB demonstrated 88.2% freedom TLR at 24 months in long lesions and 84.6% freedom from TLR at 24 months in ISR. What was the overall freedom from TLR in the IN.PACT Global Study?
83.3%
64
The Lutonix™ DCB platform offers 66 balloon sizes (AV included), more than any competitor on the market. How much bigger is our offering compared to the IN.PACT™ DCB offering (AV included)
22%
65
What was the conclusion drawn from TRANSCEND PAD, COMPARE RCT, and the Mori Study?
High-dose DCBs and low-dose DCBs are similarly efficacious at 24 months
66
True or False: Lutonix™ has the broadest size offering in the United States
True
67
True or False: Lutonix™ is the only SFA DCB with a 24 month warranty program
True
68
True or False: Lutonix™ can treat ISR and long lesions
True
69
True or False: The Lutonix™ 300 mm can reduce acquisition cost by up to 50% compared to other DCB
True
70
In what year did PI launch the 300 mm Lutonix™ 018 DCB- the longest DCB FDA-approved?
2019
71
In the Shammas single-center study, the Lutonix™ DCB-only cohort demonstrated 78.5% freedom from TLR at 5 years. What was the freedom from TLR at 5 years from the IN.PACT Global Study?
69.4%
72
What is the excipient for SurVeil™ DCB
Polyethylenimine 
73
In the IN.PACT I&II SFA Trial, what was the relative primary patency improvement over PTA for IN.PACT DCB at 12 months?
At 12 months, Kaplan-Meier primary patency was 34.4% higher in the DCB arm relative to the PTA arm (89.8% vs. 66.8%).
74
What was the bailout stenting rate for patients treated with IN.PACT DCB in the IN.PACT I&II SFA Trial?
7.3%
75
What was the Kaplan-Meier freedom from clinically-driven TLR rate in the IN.PACT DCB cohort of the IN.PACT SFA I&II Trial at 60 months?
74.5% Kaplan-Meier freedom from clinically-driven TLR at 60 months.
76
At 12 months, what was the relative primary patency improvement for Ranger DCB over PTA in the Ranger II SFA Trial?
At 12 months, Kaplan-Meier primary patency was 21.4% higher in the DCB arm relative to the PTA arm (89.8% vs. 74%)
77
What percent of patients treated with the Ranger DCB in the Ranger II SFA Trial received bailout stenting?
5%
78
The COMPARE RCT compared clinical outcomes of the low-dose Ranger DCB and high-dose IN.PACT DCB out to 24 months. What were the Kaplan-Meier primary patency results at 24 months?
70.6% primary patency at 24 months for Ranger DCB; 71.4% Kaplan-Meier primary patency at 24 months for IN.PACT DCB.
79
What is unique about the SurVeil DCB IDE Trial?
The TRANSCEND IDE Trial compared DCB against DCB, not DCB against PTA.
80
What were the Kaplan-Meier primary patency results for the SurVeil DCB and IN.PACT DCB at 24 months in the TRANSCEND PAD Trial?
70.8% Kaplan-Meier primary patency rate at 24 months for SurVeil DCB; 70.4% Kaplan-Meier primary patency rate at 24 months for IN.PACT DCB
81
What was one of the conclusions drawn from the TRANSCEND PAD IDE Trial?
The SurVeil DCB demonstrated non-inferiority to IN.PACT DCB in safety and efficacy out to 24 months.
82
What is the longest Lutonix DCB?
300mm
83
What is the paclitaxel dose on Lutonix DCB?
2ug/mm2
84
What is the paclitaxel dose on IN.PACT DCB?
3.5ug/mm2
85
What is the carrier for paclitaxel on Lutonix DCB?
Polysorbate and sorbitol
86
What is the carrier for paclitaxel on IN.PACT DCB?
Urea
87
What is the range in diameters offered for Lutonix DCB?
4mm - 12mm

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