BARD C R INC /NJ/ - FORM 8-K - EX-99.2

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8-K - FORM 8-K - BARD C R INC /NJ/	d944259d8k.htm

Lutonix Global Real World SFA

Registry -

Interim Results

First Look at LEVANT 2

24 Month Results

Chad Laurich, MD

Vascular Physician & Surgeon

Sanford Health

Sioux Falls, South Dakota

Exhibit 99.2

Disclosures/Disclaimers

•

The speaker’s presentation today is on behalf of Lutonix, Inc. Any

discussion regarding Bard products during the presentation today is

limited to information that is consistent with the Bard labeling for

those products. Please consult Bard product labels and inserts for

any indications, contraindications, hazards, warnings, cautions and

instructions for use.

•

The opinions and clinical experiences presented herein are for

informational purposes only. The results presented may not be

predictive for all studies and patients. Results may vary depending on

a variety of experimental and clinical parameters.

The LUTONIX

Global SFA Registry data reported herein:

•

Are

preliminary

interim

data

concerning

subset

691

enrolled

patients

with

follow-up

ongoing;

•

Are

subject

change

upon

completion

two-year

follow-up

and

full

adjudication;

•

Are

not

intended

compared

against

interpreted

superior

any

other

published

data

concerning

the

LUTONIX

035

DCB.

LUTONIX

Global Real World SFA

Registry

Conflicts of Interest

•

Speaker is a consultant for:

–

BARD

–

Medtronic

–

EKOS Corporation

To Demonstrate Safety and Assess the

Clinical

Outcomes

the

LUTONIX

DCB

Real-World Clinical Practice

LUTONIX

Global Real World SFA

Registry Objectives

Global Real World SFA Registry

Design

Enrollment

•

Up to 1000 patients with

femoro-popliteal lesions

•

Registry to include up to 75

sites

•

Follow up 1m, 6m, 12m and

24m by phone or at clinic

•

Patient consent for 5 year F/U

Inclusion

•

Male or non-pregnant female

years

•

Rutherford Class

•

Stenotic

or obstructive vascular

lesions of the Fem-Pop artery

treated per IFU

•

At least one patent native outflow

artery to the ankle free from

significant lesion (

50% stenosis)

as confirmed by angiography

Global Real World SFA Registry

Primary End Points

•

Freedom at 30 days from

•

TVR

•

Major limb amputation

•

Device or procedure related

death

•

Freedom from TLR at 12

months

Effectiveness

Safety

Global Real World SFA Registry Status

Enrollment ended with 691 patients

•

Global, real world, all comer data

•

Multi center participation: 38 sites

from 11 countries participated in

the Registry

•

Enrollment:

Dec

2012

–

Jul

2014

370

Enrollment by country

France

Spain

Switzerland

Poland

Belgium

Greece

Italy

Austria

Germany

Global Real World SFA Registry

Rutherford Category Distribution

*Preliminary data are site reported and subject to change upon adjudication.

11.0%

Class 2

17.6%

Class 3

62.5%

Class 4

7.3%

Class 5,6

1.6%

Global Real World SFA Registry

Lesion Characteristics

Target

Lesion

length

(mm),

mean

(n)

100.9

84.2 (684)

Calcification % (n/N)

34.2% (235/687

)

Total Occlusion, % (n/N)

30.9% (212/686)

Number of Lesions treated

83.9% (577/688)

14.2%

(98/688)

3 or more

1.8% (13/688)

Lesion location

Proximal SFA

7.8% (53/678)

Mid SFA

25.1% (170/678)

Distal SFA

37.5% (254/678)

Proximal

Popliteal

16.8% (114/678)

Mid Popliteal

10.2% (69/678)

Distal Popliteal

2.7% (18/678)

*Preliminary data are site reported and subject to change upon adjudication.

Type A

34.1%

Type B

23.9%

Type C

9.5%

Type D

4.8%

Unknown

27.7%

Lesion Class TASC II

Global Real World SFA Registry

Lesion Characteristics

*Preliminary data are site reported and subject to change upon adjudication.

Baseline DCB Demographics

LEVANT 2 vs. Global Real World SFA Registry

LEVANT 2

DCB

(316)

Global SFA Registry*

(691)

Age, Mean ±

SD (n)

67.8

10.0

(316)

68.3

9.8 (691)

Male gender, % (n/N)

61.1% (193/316)

67.6% (467/691)

Obesity

34.8% (110/316)

Current Smoker

35.1% (111/316)

36.5% (252/690)

Dyslipidemia

89.6% (283/316)

69.9% (483/691)

Diabetes

43.4% (137/316)

39.5% (273/691)

Hypertension

89.2% (282/316)

85.2% (589/691)

Rutherford Grade

29.4% (93/316)

17.6%

62.7% (198/316)

62.5%

7.9% (25/316)

7.3%

5 and 6

0.0% (0/316)

1.6%

*Preliminary data are site reported and subject to change upon adjudication.

DCB Angiographic Demographics

LEVANT 2 vs. Global Real World SFA Registry

LEVANT 2 DCB

(316)

Global SFA

Registry* (691)

Two lesions treated

1.9% (6/316)

14.2% (98/688)

Total Lesion Length (mm)

62.7 ±

41.4 (315)

100.9 ±

84.2 (684)

Treated Length (mm)

107.9 ±

47.0 (316)

197.3 ±

133.2

(202)

Calcification

59.2% (187/316)

34.2% (235/687)

Total Occlusion

20.6% (65/316)

30.9% (212/686)

Lesion Locations

SFA

90% (285/316)

70% (477/678)

Proximal

Popliteal

4.7% (15/316)

16.8% (114/678)

Mid

& Distal Popliteal

5.0% (16/316)

12.8% (87/678)

%DS post-treatment

23.4

12.3

(316)

14.3

18.3

(680)

Bail-out Stenting

2.5% (8/316)

27.6% (191/691)

Dissection

63.7% (200/314)

38.1% (263/691)

*Preliminary data are site reported and subject to change upon adjudication.

Global Real World SFA Registry

Interim 12 Month Results

Global Real World SFA Registry

Updated Interim 12 Month Results

Measure

Lutonix

DCB%

(N)

Freedom from TLR

1,2

92.0% (460)

Primary Patency

1,2

91.0% (460)

Day Safety

99.1% (687)

Preliminary data are site reported and subject to change upon adjudication.

Kaplan Meier estimates @ 12 month survival

All Cause Death

1.9%

(13/691)

Device or procedure related death

1,2

0.0%

Major index limb amputation

1,2

0.3%

(N=490)

Minor index limb amputation

1,2

0.3%

(N=490)

Reintervention for treatment of embolization to its

distal vasculature

1,2

0.4%

(N=489)

Reintervention for treatment of thrombosis of the

target vessel

1,2

0.6%

(N=489)

Global Real World SFA Registry

Updated Interim 12 Month Select Secondary Safety

Endpoints

Preliminary data are site reported and subject to change upon adjudication.

Kaplan Meier estimates @ 12 month survival

Lutonix 24 Month Outcomes

LEVANT 2

Global Real World SFA Registry

LEVANT 2 Endpoint Summary

24 Month Outcomes

Composite

Safety

Lutonix

DCB

(N=315)

Standard

PTA

(N=160)

Difference

Log-Rank

P-value

@730 days

78.7%

70.9%

7.8%

0.08

Lutonix DCB Demonstrated

Non-inferiority AND trend towards

superiority versus PTA

Composite

freedom

from

all-cause

perioperative

(<30

day)

death

and

freedom

from

the

following

24,

36,

months:

index limb amputation, index limb re-intervention and index limb related death.

Primary Safety reported based on Kaplan-Meier Survival analysis, not pre-specified

LEVANT 2 Endpoint Summary

24 Month Outcomes

Efficacy,

Primary Patency

Lutonix

DCB

(N=316)

Standard

PTA

(N=160)

Difference

Log-Rank

P-value

@730 days

58.6%

53.0%

5.6%

0.05

Lutonix DCB Showed Sustained Benefit in

Primary Patency at 24 months

Primary patency is defined as the absence of target lesion restenosis (defined by DUS peak systolic velocity ratio (PSVR) >2.5) and

freedom from target lesion revascularization (TLR).

Primary Efficacy reported based on Kaplan-Meier Survival analysis, not pre-specified.

10.5% Improvement over PTA

Lutonix DCB freedom from TLR rate of 82% is consistent

with published stent freedom from TLR rates

“Stent Like TLR” Continued

at 24 Months

86.6

77.8

75.3

80.3

79.4

84.0

100

Zilver PTX

Resilient

(Lifestent)

Durability II

(Everflex)

Stroll

(SMART)

Viastar

(Viabahn w/

propaten)

Superb

(Supera)

LEVANT 2 DCB Freedom from TLR rate = 82%

*TLR is defined as Target Lesion Revascularization. This was a secondary endpoint in the LEVANT 2 trial. Reported stent TLR rates are from Kaplan-Meier analyses at 24 months, not pre-

specified. LEVANT 2 PTA arm 79%. These data are not from head-to-head clinical studies. Comparing the results of different clinical trials can be misleading, as each study may have varying

patient profiles, protocol structures and other criteria that may affect reported outcomes. This presentation of data is provided for background and general education purposes only.

LEVANT 2

Other Selected Secondary Safety Endpoints

Outcome –

Lutonix DCB

24 Months

Death

19/277 (6.9%)

Major Amputation

1/261 (0.4%)

Reintervention

for Thrombosis

1/260

(0.4%)

Global Real World SFA Registry

24 Month Outcomes

Measure

Lutonix DCB

(N)

Freedom from TLR

1,2

76.4% (72)

Primary Patency

1,2

75.0% (72)

Preliminary data are site reported and subject to change upon adjudication.

Kaplan Meier estimates @ 24 month survival

All Cause Death

1.9% (13/691)

Device or procedure related death

0.0% (0/691)

Major

index

limb

amputation

1,2

0.3% (N=76)

Minor

index

limb

amputation

1,2

0.3% (N=76)

0.5%

(N=75)

1.2% (N=74)

Global Real World SFA Registry

24 Month Selected Secondary Safety Endpoints

Preliminary data are site reported and subject to change upon adjudication.

Kaplan Meier estimates @ 24 month survival

Reintervention for treatment of thrombosis

of the target vessel

1,2

Reintervention for treatment of embolization to

its

distal

vasculature

1,2

Summary

*Preliminary data are site reported and subject to change upon adjudication.

•

In LEVANT 2, 24 month data demonstrated:

–

Non-inferiority AND trend towards superiority in safety versus

PTA

–

Sustained benefit in primary patency versus PTA

–

Freedom from TLR rate of 82% which is consistent with

published stent freedom from TLR rates

•

Global Real World SFA Registry interim primary patency data and

freedom from TLR rates demonstrated sustained benefits of the

Lutonix

DCB over 24 months

INDICATIONS FOR USE: The LUTONIX

035 Drug Coated Balloon PTA catheter is indicated for percutaneous transluminal angioplasty, after

pre-dilatation, of de novo or restenotic lesions up to 150mm in length in native superficial femoral or popliteal arteries with reference

vessel diameters of 4-6mm.

CONTRAINDICATIONS : The LUTONIX

Catheter is contraindicated for use in: 1) Patients who cannot receive recommended anti-platelet

and/or anticoagulant therapy. 2) Women who are breastfeeding, pregnant or are intending to become pregnant or men intending to

father children. It is unknown whether paclitaxel will be excreted in human milk and there is a potential for adverse reaction in

nursing infants from paclitaxel exposure. 3) Patients judged to have a lesion that prevents complete inflation of an angioplasty

balloon or proper placement of the delivery system.

WARNINGS: Contents supplied STERILE using ethylene oxide (EO) process. Do not use if sterile barrier is damaged or opened prior to

intended use. Do not use if product damage is evident. The LUTONIX

Catheter is for use in one patient only; do not reuse in another

patient, reprocess or resterilize. Risks of reuse in another patient, reprocessing, or resterilization include: Compromising the

structural integrity of the device and/or device failure which, in turn, may result in patient injury, illness or death. Creating a risk of

device contamination and/or patient infection or cross-infection, including, but not limited to, the transmission of infectious

disease(s) from one patient to another. Contamination of the device may lead to patient injury, illness or death. Do not exceed the

Rated Burst Pressure (RBP) recommended for this device. Balloon rupture may occur if the RBP rating is exceeded. To prevent over-

pressurization, use of a pressure monitoring device is recommended. Use the recommended balloon inflation medium of contrast

and sterile saline (< 50% contrast). Never use air or any gaseous medium to inflate the balloon. This product should not be used in

patients with known hypersensitivity to paclitaxel or structurally related compounds. The safety and effectiveness of the

Lutonix

Catheter have not been established for treatment in cerebral, carotid, coronary, or renal vasculature. The safety and

effectiveness of using more than two Lutonix drug coated balloons (i.e., a maximum drug coating quantity of approximately 7.6 mg

paclitaxel) in a patient has not been clinically evaluated.

PRECAUTIONS : General Precautions: The LUTONIX

Catheter should only be used by physicians trained in percutaneous interventional

procedures. Consideration should be given to the risks and benefits of use in patients with a history of non-controllable allergies to

contrast agents.

POTENTIAL ADVERSE EVENTS: Potential adverse events which may be associated with a peripheral balloon dilatation procedure include:

Additional intervention, allergic reaction to drugs, excipients or contrast medium, amputation/loss of limb, aneurysm or

pseudoaneurysm, arrythmias, embolization; hematoma; hemorrhage, including bleeding at the puncture site,

hypotension/hypertension, inflammation, occlusion, pain or tenderness, pneumothorax or hemothorax, sepsis/infection, shock,

stroke, thrombosis, vessel dissection, perforation, rupture, or spasm. Although systemic effects are not anticipated, refer to the

Physicians’ Desk Reference for more information on the potential adverse events observed with paclitaxel. Potential adverse events,

not described in the above source, which may be unique to the paclitaxel drug coating include: Allergic/immunologic reaction to the

drug coating (paclitaxel), alopecia, anemia, blood product transfusion, gastrointestinal symptoms, hematologic dyscrasia (including

leukopenia, neutropenia, thrombocytopenia), hepatic enzyme changes, histologic changes in vessel wall, including inflammation,

cellular damage, or necrosis, myalgia/arthralgia, myelosuppression and peripheral neuropathy.

Bard, Advancing Lives and the Delivery of HealthCare and Lutonix are trademarks and/or registered trademarks of C. R. Bard, Inc., or an

Please consult product labels and instructions for use for indications, contraindications, hazards, warnings and precautions. RX Only.

Thank You

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