an overview of the lutonix™ drug · *includes isr and cv. kaplan-meier method, itt subjects data...

An Overview of the Lutonix™ Drug Coated Balloon Clinical Program and

Patient Population Characteristics

Tobias Steinke, MD

Chefarzt Gefäßchirurgie, Schön KlinikDüsseldorf, Deutschland

Disclosure

Speaker name:

Dr. Tobias Steinke

I have the following potential conflicts of interest to report:

X Consulting (BD, Merit Medical, Medtronic)

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

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• The speaker’s presentation today is on behalf of BD/Lutonix, Inc. The physician has

been compensated by Lutonix for the time and effort to present this information.

• Please consult BD product labels and inserts relevant to your geography for

indications, contraindications, hazards, warnings, cautions, and instructions for use.

• The opinions and clinical experiences presented herein are for informational and

educational 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. Individual

results may vary depending on a variety of patient specific attributes.

Disclosures/Disclaimers

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IDE Global Registry Post Approval Study

Number of Patients/Sites

285 subjects 23 U.S. clinical sites

320 subjects25 International Sites

213 subjectsUp to 30 U.S. and Canadian Sites

Primary Effectiveness Endpoint

TLPP 6 Months TLPP 6 Months TLPP 6 Months

Primary Safety Endpoint

Freedom from any serious adverse event(s) involving the AV access circuit through 30 days



Follow Up 1, 3, 6, 9, 12, 18, 24 3, 6, 12 months 6, 12, 18, 24 months

Status Completed Enrolled Enrolling

TypeProspective, Randomized, Core Lab

Prospective, Single arm, Real World

Prospective, Single arm, Core lab

Lesion Characteristics

Mature, dysfunctional fistulae. Central vein and ISR excluded. Restenotic and previous thrombosis included

Real World treated lesions; Central vein, ISR, AVG/AVF, Cephalic Arch, Restenotic, previous thrombosis, etc. included.

PI Scott O. Trerotola, MDDimitris Karnabatidis, MD, PhD

Dheeraj Rajan, MDScott O. Trerotola, MD

Lutonix AV Clinical Trials

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Lutonix AV IDE TrialKey Inclusion Criteria – “Real World Patient Population”

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Lutonix AV IDE Clinical TrialTarget Lesion Location

DCB(n=141)

PTA (n=144)

Anastomotic (%) 4.3% 3.5%

Cephalic arch (%) 18.7% 22.5%

Cannulation zone (%) 4.3% 9.9%

Inflow (%) 33.8% 29.6%

Outflow (%) 24.5% 22.5%

Swing point (%) 14.4% 12.0%

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Lutonix AV IDE Clinical Trial6 & 24 Month Publications

Trerotola et al, Clin J Am Soc Nephrol2018 Aug 7;13(8):1215-1224

Trerotola et al, JVIR2019 online; Print 2020; 31:1–14

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Lutonix AV IDE Clinical TrialEfficacy- 24 Month TLPP

*One-sided p-value Data shown is final.

LTX DCB

(N=141)

Standard PTA

(N=144)

Difference

% (95% CI) P-value*

730 Day Event Free 0.0869

Rate (SE) 26.9% (4.4%) 24.4% (3.0%) 2.5% (5.9%)

95% CI (18.6%, 35.8%) (17.2%, 32.3%) (-9.1%, 14.0%)

71.4% TLPP at

6 Months

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Lutonix AV IDE Clinical TrialInterventions Required to Maintain TLP

Patients may have required more than one intervention,

*One-sided p-value

Data shown is final

LTX DCB

(n=141)

StandardPTA

(n=144)

P-value* % Fewer Interventions

than PTA

Number of interventions, 6 Months

44 64 0.034 31.3% Fewer


75 102 0.021 26.5% Fewer


113 137 0.079 17.5% Fewer

Number of interventions,18 Months

160 184 0.125 13.0% Fewer


208 223 0.19 6.7% Fewer

31.3% Fewer interventions to maintain TLP at 6 months

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10+ Months- Time to First Event-TLPP

*Control arm includes successful predilatation in addition to control balloonData shown is final

207.4

321.8

0 50 100 150 200 250 300 350

Control Arm

Lutonix DCB

Mean Reintervention-Free Days - Interim

24 Months

Control Arm Lutonix DCB

*

Lutonix AV IDE Clinical TrialTime to First Event

114 More (~4 months)

Reintervention-Free Days

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Primary Safety Endpoint: Non-inferior to PTA

LTX DCB

(N=141)

Standard PTA

(N=144)

Difference

% (95% CI) P-value

730 Day Event Free 0.0004

Rate (SE) 20.6% (3.9%) 16.5% (3.3%) 4.2% (5.1%)

95% CI (13.6%, 28.7%) (10.6%, 23.4%) (-5.9%, 14.2%)

Primary Safety Endpoint- 30 Days Freedom from any serious adverse event(s) involving the AV access circuitData shown is final.

Lutonix AV IDE Clinical TrialSafety- 24 Months

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IDE Global Registry Post Approval Study

Number of Patients/Sites

285 subjects 23 U.S. clinical sites

320 subjects 25 International Sites

213 subjectsUp to 30 U.S. and Canadian Sites

Primary Effectiveness Endpoint

TLPP 6 Months TLPP 6 Months TLPP 6 Months

Primary Safety Endpoint




Follow Up 1, 3, 6, 9, 12, 18, 24 3, 6, 12 months 6, 12, 18, 24 months

Status Completed Enrolled Enrolling

TypeProspective, Randomized, Core Lab

Prospective, Single arm, Real World

Prospective, Single arm, Core lab

Lesion Characteristics

Mature, dysfunctional fistulae. Central vein and ISR excluded. Restenotic and previous thrombosis included

Real World treated lesions; Central vein, ISR, AVG/AVF, Cephalic Arch, Restenotic, previous thrombosis, etc. included.

PI Scott O. Trerotola, MD Dimitris Karnabatidis, MD, PhDDheeraj Rajan, MDScott O. Trerotola, MD

Lutonix AV Clinical Trials

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Synthetic Graft – 25%

Native Fistula – 75%

Restenotic ISR Central Vein

52.9% 11.1% 11.6%

Mean Target Lesion Length 32.0mm + 20.86mm

Lutonix AV Global Registry“Real World” Lesion Characteristics

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Lutonix AV Global RegistryAccess Location

47.5% Upper Arm

11.3% Antecubital Fossa

41.3% Forearm

Left Arm: 73.4%Right Arm: 26.6%

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Lutonix AV Global Registry73.9% TLPP at 6 Months

Kaplan-Meier Method, ITT subjectsData shown is final per CiRSE 2019 Kitrou, P. The Lutonix Global AV Registry: Final 6-Month Results & Subgroup Analysis of Target Lesion Location.

Real World treated lesions:Central vein, ISR, AVG/AVF, Cephalic Arch,Restenotic

73.9% TLPP

IDE TLPP 71.4% at 6 months

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Lutonix AV Global RegistryTLPP by Access Type: Fistula*/Graft*

*Includes ISR and CV.


78.1%

61.9%

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Lutonix AV Global Registry96.1% Freedom from Primary Safety Events


96.1%

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Variable Level TLPP P-Value

Vessel Prep? Yes 77.0% 0.0005

No 48.6%

Inflation Time 50-120 seconds 67.9% 0.0074

120-180 seconds 79.8%

180-240 seconds 75.0%

Lutonix AV Global RegistryExploratory Subgroup Analyses

TLPP at 6 Months

180 day-TLPP response estimate based on KM estimates.Data shown is interim, site reported, and subject to change

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•>800 subjects part of a Lutonix AV protocol*

•6 month TLPP similar between IDE and GR

• Procedural variables matter (GR)

•Additional analyses to follow

–Next step: Post-approval Study, now enrolling

(n=213)

Lutonix AV Clinical ProgramSummary

*Pending Lutonix Post Approval Study full enrollment

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INDICATIONS FOR USE EU The LUTONIX® 035 Drug Coated Balloon Catheter is intended for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature and for the treatment of obstructive lesions and decreasing the incidence of restenosis. In addition, the Lutonix® 035 Drug Coated Balloon Catheter is intended for PTA of native dialysis fistulae or synthetic grafts, opening narrowing and immature fistulae, to improve blood flow, and decreasing the incidence of restenosis.

INDICATIONS FOR USE US The LUTONIX® 035 Drug Coated Balloon Catheter is intended for Percutaneous Transluminal Angioplasty (PTA) after pre-dilatation, for treatment of stenotic lesions of dysfunctional native arteriovenous dialysis fistulae that are 4 mm to 12 mm in diameter and up to 80mm in length.

CONTRAINDICATIONS 1) Women who are breastfeeding, pregnant or are intending to become pregnant or men intending to father children over the next 2 years. 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. 2) Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system. 3) Patients who cannot receive recommended anti-platelet and/or anticoagulant therapy.

WARNINGS A signal for increased risk of late mortality has been identified following the use of paclitaxel-coated balloons and paclitaxel-eluting stents for femoropopliteal arterial disease beginning approximately 2-3 years post-treatment compared with the use of non-drug coated devices. There is uncertainty regarding the magnitude and mechanism for the increased late mortality risk, including the impact of repeat paclitaxel device exposure. Inadequate information is available to evaluate the potential mortality risk associated with the use of paclitaxel-coated devices for the treatment of other diseases/conditions, including this device indicated for use in arteriovenous dialysis fistulae. Physicians should discuss this late mortality signal and the benefits and risks of available treatment options with their patients.

1) Contents supplied STERILE using ethylene oxide (EO) process. Do not use if sterile barrier is damaged or opened prior to intended use. 2) Do not use after the “Use by” date. 3) Do not use if product damage is evident. 4) 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. 5) 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. 6) Use the recommended balloon inflation medium of contrast and sterile saline (≤50% contrast). Never use air or any gaseous medium to inflate the balloon as this may cause air emboli in case of balloon burst. 7) This product should not be used in patients with known hypersensitivity to paclitaxel or structurally related compounds as this may cause allergic reaction (difficulty in breathing, skin rash, muscle pain).

PRECAUTIONS General Precautions: 1) The Lutonix® Catheter should only be used by physicians trained in peripheral vascular percutaneous interventional procedures. 2) Consideration should be given to the risks and benefits of use in patients with a history of non-controllable allergies to contrast agents. 3) The safety and effectiveness of the LUTONIX® Catheter have not been established for treatment in cerebral, carotid, coronary, or renal vasculature. 4) The safety and effectiveness of using multiple Lutonix® drug coated balloons that deliver greater than 7.6 mg paclitaxel in a patient has not been clinically evaluated.

POTENTIAL ADVERSE EFFECTS Potential adverse events which may be associated with a PTA balloon dilation procedure include, but are not limited to, the following: · Additional intervention · Allergic reaction to drugs or contrast medium · Aneurysm or pseudoaneurysm ·Arrhythmias · Embolization ·Hematoma · Hemorrhage, including bleeding at the puncture site · Hypotension/hypertension · Inflammation · Loss of permanent access · Occlusion · Pain or tenderness · 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, but are not limited to, the following: · 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 · Peripheral neuropathy

Please consult product labels and instructions for use for indications, contraindications, hazards, warnings & precautions. There may be other potential adverse events that are unforeseen at this time.

BD-15169

Thank you!

An Overview of the Lutonix™ Drug Coated Balloon Clinical Program and

Patient Population Characteristics

Tobias Steinke, MD

Chefarzt Gefäßchirurgie, Schön KlinikDüsseldorf, Deutschland

an overview of the lutonix™ drug · *includes isr and cv. kaplan-meier method, itt subjects data...

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