Clinical Design of the FIRST

and ONLY Approved IDE BTK Trial for

a Drug Coated Balloon

Caution –

Investigational Device, Limited by Federal (USA) Law to Investigational Use

Patrick Geraghty, MD, FACS

Associate Professor of Surgery and Radiology

Co-Director, Limb Preservation Center

Washington University Medical School

St. Louis, MO

Exhibit 99.1

Disclaimer

This presentation is on behalf of Lutonix, Inc., a

subsidiary of C.R. Bard, Inc. It is intended as an update

and exchange of scientific and clinical trial information.

The presenter is a consultant of Lutonix, Inc. and Bard

Peripheral Vascular, Inc.

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.

Conflicts of Interest

•

Bard-Lutonix: BTK Trial PI, Advisory Board,

Consultant

•

Cook Medical: FORMAT Trial PI, Consultant

•

Boston Scientific: Advisory Board

•

Spectranetics: Steering Committee

Trial Summary

PRIMARY ENDPOINTS

Safety at 30 days

Limb salvage & primary patency at 12 months

NUMBER OF

PATIENTS/SITES

320 randomized patients at 55 global sites

FOLLOW-UP

Clinical: 1, 6, 12, 24, and 36 Months

Duplex Ultrasound (DUS):

1, 6,12, 24, & 36 months

Angiography :  12 months

Telephone: 48 and 60 Months

NATIONAL PRINCIPAL

INVESTIGATORS

Patrick Geraghty:  Washington University, St. Louis, MO

Jihad Mustapha:  Metro Health Hospital, Wyoming, MI

Marianne Brodmann:  Medical University Graz, Austria

SPONSOR

Lutonix Inc., Minneapolis, MN

Caution –

Investigational Device, Limited by Federal (USA) Law to Investigational Use

Primary Endpoints

•

New  bypass graft

•

Jump/Interposition graft revision

•

Thrombectomy/Thrombolysis

Caution

–

Investigational

Device,

Limited

by

Federal

(USA)

Law

to

Investigational

Use

SAFETY

Freedom from Major Adverse

Limb Events & All-Cause Death at

30 DAYS

Amputation (above ankle)

Major re-intervention

EFFICACY

Composite of Limb Salvage and

Primary Patency at 12 Months

Defined as freedom from the

composite of above ankle

amputation, target vessel

occlusion, and clinically-driven

target lesion re-intervention.

Patient Eligibility

Inclusion Criteria

•

Male or non-pregnant female

18 years of age

•

Rutherford 4-5

•

Life expectancy 

1 year

•

Significant stenosis

(

70%)

•

A patent inflow artery

•

Target vessel(s) diameter

between 2 and 4 mm

•

Target vessel(s) reconstitute(s)

at or above the ankle

Exclusion Criteria

•

Pregnant or planning on

becoming pregnant

•

History of stroke within 3

months

•

History of MI, thrombolysis or

angina within 30 days of

enrollment

•

Prior or planned major

amputation

•

GFR

30

ml/min

per

1.73m

•

In-stent restenosis

of target

lesion

Caution

–

Investigational

Device,

Limited

by

Federal

(USA)

Law

to

Investigational

Use

2

•

Acute limb ischemia

BTK Trial Design

Protocol Features

•

Randomized 2:1 versus POBA

•

Permits treatment of two tibial arteries (two flow pathways)

•

Combined lesion length of up to 32 cm treatable (36 cm balloon

length allowed)

•

Retrograde wire access permitted, but not retrograde intervention

•

Balloon lengths of up to 12 cm

•

First U.S. use of tibial patency assessment via duplex ultrasound

(VasCore)

•

Angiographic assessment of normal-risk subset at one year

(Synvacor)

•

Broad range of secondary endpoints including QOL instruments

Caution –

Investigational Device, Limited by Federal (USA) Law to Investigational Use

Study Flowchart

PTA Pre-Dilatation

With Uncoated Balloon

Successful PTA with

Outflow

Randomize 2:1

Test Arm:

Dilatation of ALL target lesions with

Drug Coated Balloon

Control Arm

:

Dilatation of ALL target lesions with

Uncoated Balloon

Suboptimal PTA

Absence of above ankle reconstitution

>75% residual stenosis

Treat per standard

practice

30 day follow-up for safety

Inflow Treatment

If needed

Caution –

Investigational Device, Limited by Federal (USA) Law to Investigational Use

DMC Monitoring

Caution –

Investigational Device, Limited by Federal (USA) Law to Investigational Use

What is the Data Monitoring Committee?

Unbiased panel of leading experts in peripheral

vascular disease, cardiovascular medicine and

biostatistics not associated with Lutonix or the trial

During the enrollment phase of the trial, DMC

reviews accumulating safety data to monitor for

incidence of serious vascular events that would

warrant termination of the trial

Safety Review

Caution –

Investigational Device, Limited by Federal (USA) Law to Investigational Use

6 Data Monitoring Committee meetings so far

213 randomized patients:

128 have completed 6 month follow-up

69 have completed 12 month follow-up

Only 7 major amputations (3.27% of enrolled pts)

recorded

Only approved and ongoing BTK trial in the US