luminor 14 18 35 - Limit · PDF fileluminor 14 18 35. Inhibition of ... LUMINOR DRUG ELUTING...

LAUNCH OF 018 FAMILY (DEB & POBA)

luminor 14 18 35

Inhibition of proliferation of smooth muscle cells and neointimal hyperplasia in the injury under

treatment

Objective

Clinical use

Prompt drug release without the need of polymer

Prevents chronic inflammation

After the procedure, nothing remains in the vessel

Reduction of the dual antiplatelet treatment

– Patients allergic to drugs

– Patients expected to undergo future surgeries

– Patients at risk of quitting treatment

Cases where angioplasty with bare stent or DES is not a

feasible alternative

Benefits

LUMINOR DRUG ELUTING BALLOON

The therapy

NAVIGATION INJURY DOWNSTREAM

PR

OS •Low profile

•Durability

•Light solubilization of the coating

•Fast drug absorption

•Drug uniformity and dose

•Drug retention vs. time

•Drug crystallinity

•Particle release

•Delamination

CO

NS •Overdose

•Coating not prepared

•High adhesion to balloon

•Drug in amorphous state

•Particle loss


Key features

1. Drug

2. Dose

3. Excipient

4. Drug / excipient ratio

5. Balloon shape before coating

6. Crystalline structure

– Impact on pharmacological efficacy

7. Coating technology

– Transfertech

8. Catheter design

– Pushability & trackability

– Radiopaque markers

– Tip

9. Inflation time

10. Available sizes and references

11. Safety, Efficacy and

Pharmacokinetics

– Preclinical study


Elements

• Strong inhibition of stenosis: Blocks proliferation and migration of smooth muscular cells, fibroblasts and

inflammatory cells. Blocks secretion of ECM (extracellular matrix).

• Highly lipophilic: Fast and high absorption. Bonds to the tissue in target locus and remains after washing.

(Limus: limited lipophilicity).

• Specific cellular receptors. Diffuses from endothelial surface to medium and adventitia layers of arterial wall.

(Limus: low number of receptors)

C47H51NO14

Paclitaxel

PACLITAXEL


1. Drug: paclitaxel

The higher the dose the higher the profile of the coated balloon

Therapeutic window: between 1 – 9 µg/mm2

2,5 – 3,5 µg/mm2


2. The dose: 3 µg/mm2

Water Reduced Ester

• Controls coating integrity and drug loss during navigation

• Facilitates absorption in tissues: increases exposition and accelerates drug release and transfer to vessel wall

• Required to achieve therapeutic dose of drug.


3. Excipient: water reduced ester

• DRUG / excipient higher risk of drug loss during navigation.

• drug / EXCIPIENT higher risk of blocking drug transfer to arterial wall

The higher the excipient ratio, the larger the amount of coating to

achieve the same dose (3 μg/mm2). Higher balloon profile.

80/20


4. Drug/excipient ratio: 80/20

PROS CONS

Folded-

Inside the wings

Balloon wings protect the coating

Minimization of losses during navigation

Micropippeting. Non homogeneous coating

Accumulation in wing corners due to capillarity

High profiles

High risk of delamination

No coating preparation before balloon inflation

Folded-

Outside the wings

Uniform and homogeneous

Gel effect: light solubilization during navigation

Preparation for optimal transfer Little loss during navigation due to solubilization

Expanded

Uniform and homogeneous.

Gel effect: light solubilization during navigation

Preparation for optimal transfer

Higher risk of distal embolization

Folded- Outside the wings


5. Coating strategy

Crystalline Amorphous

Particle release

Coating uniformity

Drug-vessel transfer

Drug retention vs time

Biological effectiveness

crystalline


6. Crystalline structure

TransferTech

DEB

luminor 14 luminor 35

BALLOON CATHETER

oceanus

COATING

EXCIPIENT

Water Reduced Ester

DRUG

Paclitaxel - 3 µg/mm2

COATING PERFORMANCE:

20% excipient

80% coating technology


7. Coating strategy

TransferTech Dosage of uniform diameter nanodrops by direct ultrasonic deposition

Ultrathin multilayer coating:

• Increases adhesión to balloon lower loss related to manipulation

• Improves durability lower loss during navigation

• Improves mechanical properties

Homogeneus distribution of drug

• Same dose along the entire length

Repeatible drug load: 2.5 – 3.5 µg/mm2



http://www.google.es/url?sa=i&rct=j&q=water+drops&source=images&cd=&cad=rja&docid=kxWww_lxBbXeEM&tbnid=wVofWEhZvC4rdM:&ved=0CAUQjRw&url=http://www.wallpaperdev.com/wallpaper/1680x1050/tiny-water-drops-wallpaper-by-kingl-57015.html&ei=1_t4UYSVFsSq0QWp4oCYDQ&bvm=bv.45645796,d.ZG4&psig=AFQjCNE5YVsH_wwT5emOLPD0N2g60JOXsw&ust=1366969525711633

TransferTechluminor

IN.PACT Admiral



TransferTech Control over drug morphology

CRYSTALLINE

PACLITAXEL

SEM: magnify: x250

SEM: magnify: x 1000

Paclitaxel microcrystalline structure

Drug molecules not clumped

Minimum loss during navigation and

inflation

Fast absorption: 30-60s

Excellent drug transfer to arterial wall



Technical Features

PRODUCT GUIDEDOSE

(µg/mm2)EXCIPIENT PX/EXC STATE PX

HYDRO

PHILIC

COATING

INFLA

TION

TIME

(s)

TECHNO BALLOON

SHAFT

LENGTH

(cm)

SHEATH

SIZING SIZE

(F)

BALLOON

Ø (mm)

BALLOON

LENGTH

(mm)

luminor 14 0,014’’ 3

Water

Reduced

Ester

80/20 Crystalline No 30-60

Outside

of

folded

balloon

3 folded100,

1504

1,5-2-

2,5-3-

3,5-4

40-60-

80-120-

150-200

luminor 18 0,018’’ 3

Water

Reduced

Ester

80/20 Crystalline No30-60

Outside

of

folded

balloon

Φ 2-5 mm-

3 folded

Φ 6- 8 mm-

5 folded

100,

140, 150

4 (2-4 mm)

5 (5-8 mm)

2-2,5-3-

3,5-4-5-

6-7-8

20-40-

60-80-

120-150-

200

luminor 35 0,035’’ 3

Water

Reduced

Ester

80/20 Crystalline No30-60

Outside

of

folded

balloon

5 folded 80, 1405 (5 mm)

6 (6-7 mm)5-6-7

20-40-

60-80-

120-150


Competitive Landscape

COMPANY 0,014’’ 0,018’’ 0,035’’

AACHEN RESONANCE Elutax SV Rx Elutax SV OTW -

BARD Lutonix 14 Lutonix 35

BIOTRONIK - Passeo Lux -

BOSTON SCIENTIFIC - Ranger -

CARDIONOVUMLegFlow 014 OTW/

Legflow 014 RXLegflow 018 LegFlow 035

COOK - Advance 18 PTX -

EUROCOR Freeway 014 - Freeway 035

MEDRAD Cotavance - -

MEDTRONIC - IN.PACT Pacific IN.PACT Admiral

MINVASYS Danubio 014 - -

BIOSENSORS BioPath 014 - BioPath 035

SPECTRANETICS — - Stellarex

iVASCULAR luminor 14 luminor 18 luminor 35


COMPANY PACLITAXEL DOSE EXCIPIENT RATIO DRUG/EXCIP. COATING STRATEGY MORPHOLOGY

3 µg/mm2 No 100/0 Expanded Crystalline

3 µg/mm2 Ultravist 370 67/33 Outside Crystalline

3 µg/mm2 BTHC 90/10 Inside Crystalline

3 µg/mm2 ? ? Inside Amorphous

3 µg/mm2 Polysorbate and

sorbitol? Expanded ?

3 µg/mm2 Shellac 50/50 Inside Amorphous

3 µg/mm2 No 100/0 Inside Crystalline

3 µg/mm2 Shellac 50/50 Inside Amorphous

3 µg/mm2 Ultravist 370 67/33 Inside Crystalline

*4-5 µg/mm2 Urea 80/20 Outside Crystalline

2.5 µg/mm2 BTHC 90/10 Inside Crystalline

3 µg/mm2 Water Reducer

Ester80/20 Outside Crystalline *Data from

iVascular


7. Coating technology: benchmark

MAIN FEATURES

Coaxial catheter (OTW) Nominal pressure: 7 atm

Working catheter length: 100 and 150 cm Rated Burst Pressure (RBP): 16 atm

Guide wire compatibility: 0.014’’ Average Burst Pressure (ABP): 22 atm

Introducer: 4F Tip profile: 0.017’’

The platform: luminor 14 >> oceanus 14


Sizes: luminor 14

4 F


0.014

100 cm 40 60 80 120 150 200

1.5

2.0

2.5

3.0

3.5

4.0

150 cm 40 60 80 120 150 200

1.5

2.0

2.5

3.0

3.5

4.0

MAIN FEATURES

Coaxial catheter (OTW) Nominal pressure: 7 atm

Working catheter length: 100, 140 and 150 cm Rated Burst Pressure (RBP): 16 atm (14 atm for Ø 8 mm)

Guide wire compatibility: 0.018’’ (0.014’’ optional) Average Burst Pressure (ABP): 20 atm

Introducer: 4F and 5F (6, 7, 8 mm) Tip profile: 0.019’’/ Crossing profile: from 0.035’’ to 0.063’’

luminor 18


0.018

100 cm20 40 60 80 120 150 200

2.0

2.5

3.0

3.5

4.0

5.0

6.0

7.0

8.0

5 F 4 F

luminor 18

Technical features: sizes

140 cm 20 40 60 80 120 150 200

5.0

6.0

7.0

8.0

150 cm 20 40 60 80 120 150 200

2.0

2.5

3.0

3.5

4.0

5 F 4 F

luminor 18

Technical features: sizes

MAIN FEATURES

Coaxial catheter (OTW) Nominal pressure: 6/7 atm

Working catheter length: 80 and 140 cm Rated Burst Pressure (RBP): 16 atm

Guide wire compatibility: 0.035’’ Average Burst Pressure (ABP): 23 atm

Introducer: 5F Tip profile: 0.037”



Sizes: luminor 35

5 F


0.035

80 cm 20 40 60 80 120 150

5.0

6.0

7.0

140 cm 20 40 60 80 120 150

5.0

6.0

7.0

6 F

Key selling points

1. Drug: Paclitaxel

2. Proprietary coating technology

Coating: Multilayer, ultrathin, uniform

Increases: mechanical properties, adhesion, durability

Reduces: thickness, losses, delamination

Drug with crystalline structure

o Less detachment

o Better transfer (quick and quantitative)

o Higher retention

o Biological efficacy


oceanus 14 18 35

1. Pushability / Trackability

2. Crossing Profile

3. Inflating and deflating time

Technical features: oceanus

oceanus 14 18 35

1. Pushability and trackability

• Structure (flexibility)

• Hydrophilic Coating

• Radiopaque Markers

Technical features: pushability & trackability

oceanus 14 18 35

SHAFT FEAT. ADDED VALUED

ES

IGN

Conic

oceanus 14 & 18

• Proximal pushability

• Smooth transition

• Distal flexibility

• Balance between flexibility and pushability

Double lumen

oceanus 35

• Guide wire lumen: always the same size, 0.037’’

• Deflating lumen: maximize deflation lumen without compromising the

wall thickness in order to obtain the best balance between pushability

and deflating capability

• The catheter body is more rigid if the wall is thick

• The device losses pushability and trackability if the Wall is thin

Pushability & trackability: structure

oceanus 14 18 35

Sterling 3mm

Sterling 8mm

Passeo-18 3mm

oceanus 18 7 / 8mm

3,96 French

4,77 French

20cm

3,30 French

3,60 French

4,71 French

3,69 French

Flexibility 1478 mN

Flexibility 3169 mN

Flexibility 1693 mN

Flexibility 2295 mN 1107 mN

Flexibility 4006 mN 2010 mN

PROGRESSIVE

TRANSITION


oceanus 14 18 35

Armada 35 Evercross

Rival

Admiral Xtreme

Mustang

oceanus 35

∙ Catheter wall reinforced

∙ Maximize in/deflation times and guidewire

lumens without comprising deliverability


oceanus 14 18 35

OCEANUS 35






oceanus 14 18 35

Acceptable limit Detection limit

∙ A good hydrophilic coating has a COF below 0.1

∙ Non-durable hydrophilic coating releases particles to the blood flow with the potential risk of micro-thrombus

∙ HYDRAX is a durable hydrophilic coating that keeps its properties during the whole procedure even on

challenging lesions

Pushability & trackability: hydrophilic coating

oceanus 14 18 35

Sterling 3mm

Sterling 8mm

Passeo-18 3mm

oceanus 18 2 - 6mm

oceanus 18 7 / 8mm

27cmBalloon + distal shaft

COF 0,050±0,020

Just the balloon

COF not measurable

Balloon + distal shaft

COF ?

++TRACKABILITY

Pushability & trackability: hydrophilic coating

oceanus 14 18 35






oceanus 14 18 35

PRODUCT Nº OF MARKERS MATERIAL IMAGE

Armada 14:

2.00 x 200mm2 Polymer + tungsten

Nanocross:

2.00 x 150mm2 Platinum-Iridium

Amphirion Deep:

2.00 x 120mm2 Platinum-Iridium

oceanus 14:

2.00 x 150mm2 Polymer + tungsten MORE FLEXIBLE

NO KINKS

Pushability & trackability: radiopaque markers

oceanus 14 18 35

OCEANUS 14

COMPANY PRODUCT MATERIAL LENGTH

Boston Scientific Sterling Au 1.3 mm

Biotronik Paseo-18 Pt / Ir 1.0 mm

iVascular oceanus 18 Pt / Ir 1.0 mm

++ FLEXIBILITY

Technical features: trackability

oceanus 14 18 35

OCEANUS 18 & 35


2. Crossing Profile

3. Inflation and deflation time

Technical features: oceanus

oceanus 14 18 35

2. Entry profile/ penetration / cross

• Tip

• Folding/ refolding

Technical features: crossing profile

oceanus 14 18 35

ENTRY

TIP FEAT. ADDED VALUE

Length 2,75 mm Long Tip with good entry lesion capability

Tip Profile

Tip entry profile

0,016”

0,026”

The best combination between the tip entry profile, the tip profile and the

tip material give us the lowest profile for the best tip entry

CROSSING

BALLOON FEAT. ADDED VALUE

Wall thickness 0,014 mm Given a low crossing profile keeping the standard working atmosphere.

Radiopaque markers Tungsten

(Polymeric)

Increase flexibility to reach narrow and tortuous anatomies.

Eliminates the risk of Kinking

Product profile

oceanus 14 18 35

OCEANUS 14

ENTRY

TIP FEAT. ADDED VALUE

Length 3,00 mm Long tip with good entry lesion capability

Tip Profile

Tip entry profile

0,0362”

0,061”

The best combination between the tip entry profile, the tip profile and the

tip material give us the lowest profile for the best tip entry

CROSSING

BALLOON FEAT. ADDED VALUE

Wall thickness

Min. 0,025 mm

Max. 0.037

mm

Given a low crossing profile keeping the standard working performance

Product profile

oceanus 14 18 35

OCEANUS 35

Armada 14

Ø 2.00 x L 200mm

Nanocross:

Ø 2.00 x L 150mm

Amphirion Deep:

Ø 2.00 x L 120mm

0,488mm = 0,0192” 0,438mm = 0,0172”

0,445mm = 0,0175” 0,419mm = 0,0165”

oceanus 14:

Ø 2.00 x L 150mm

Product profile- entry: tip

oceanus 14 18 35

OCEANUS 14

Baloon Ø 3mm Baloon Ø 8mm

Sterling

oceanus 18

Paseo-18

Ø 0,455mm

Ø 0,509mm

Ø 0,581mm

Ø 0,520mm

Ø 0,495mm


oceanus 14 18 35

OCEANUS 18

Armada 35

8.0x40mm

1,214mm = 0,0477”

Evercross

7.0x20mm

0,933mm = 0,0367”

Admiral Xtreme

6.0x20mm

0,995mm = 0,0392”

Rival

4.0x40mm

1,067mm = 0,0420”

Mustang

7.0x200mm

0,910mm = 0,0358”

oceanus 357.0x80mm

0,921mm = 0,0362”

∙ Soft atraumatic finished tip

∙ Embrace the guide avoiding any injury to the vessel wall


oceanus 14 18 35

OCEANUS 35

Armada 14:

Ø 2.00 x L 200mmNanocross:

Ø 2.00 x L 150mm

Amphirion Deep:

Ø 2.00 x L 120mm

0,673mm = 0,0265” / 3,52mm 0,631mm = 0,0248” / 2,82mm

0,714mm = 0,0281” / 2,64mm

oceanus 14:

Ø 2.00 x L 150mm

0,627mm = 0,0246” / 3,01mm

Crossing profile: tip- balloon welding

oceanus 14 18 35

OCEANUS 14

Baloon Ø 3mm Baloon Ø 8mm

Sterling

oceanus 18

Paseo-18

Ø 0,701mm

Ø 0,841mm

Ø 1,054mm

Ø 1,163mm

Ø 1,049mm


oceanus 14 18 35

OCEANUS 18

Armada 35

8.0x40mm

1,822mm = 0,0717”

Evercross

7.0x20mm

1,620mm = 0,0637”

Admiral Xtreme

6.0x20mm

1,633mm = 0,0643”

Mustang

7.0x200mm

1,514mm = 0,0596”

oceanus 357.0x80mm

1,544mm = 0,0607”

Rival

4.0x40mm

1,661mm = 0,0654”

∙ Smooth conical welding progressive transition allows crossing lesions easily


oceanus 14 18 35

OCEANUS 35

NAME WINGS Nº

BALLOON

WALLTHICKNES

S

FOLDED PROFILENº WINGS

REFOLDED

Armada 14

2.0x200mm3 14 – 15 µm

0.72 ± 0.03mm

(0.0283”)2

Nanocross

2.0x150mm3 15 – 16.5 µm

0.71 ± 0.05mm

(0.0279”)2

Amphirion Deep

2.0x120mm3 20.5 µm

0.70 ± 0.03mm

(0.0276”)2

oceanus 142.0x150mm

3 11 – 13 µm0.62 ± 0.03mm

(0.0244”)2

Crossing profile: folding-refolding

oceanus 14 18 35

OCEANUS 14

PRODUCT 3mm Nº WINGSBALLOON

TICKNESSFOLDING PROFILE

Nº OF WING

RE-FOLDED

Sterling 3 19 µm 0,90 ± 0,04 2

Paseo-18 3 16 µm 0,98 ± 0,08 2

oceanus 18 3 17 µm 0,82 ± 0,02 2

PRODUCT 8mm Nº WINGSBALLOON

TICKNESSFOLDING PROFILE

Nº OF WING

RE-FOLDED

Sterling 5 34 µm 1,60 ± 0,07 2

oceanus 18 5 33 µm 1,49 ± 0,03 2


oceanus 14 18 35

OCEANUS 18

PRODUCT 3mm ENTRY PENETRATION CROSSABILITY

Sterling 0,0200” 0,0331” 0,0354”

Paseo-18 0,0229” 0,0415” 0,0386”

oceanus 18 0,0179” 0,0276” 0,0323”

PRODUCT 8mm ENTRY PENETRATION CROSSABILITY

Sterling 0,0205” 0,0458” 0,0630”

oceanus 18 0,0195” 0,0413” 0,0587”

++ CROSSABILITY


oceanus 14 18 35

OCEANUS 18


2. Crossing Profile

3. Inflation and deflation time

Technical features

oceanus 14 18 35

PRODUCT ATM FLUID TIME

Armada 14:

2.00 x 200mm

14

Contrast media:

deionized water

1:1

16”60

Nanocross:

2.00 x 150mm10”29

Amphirion Deep:

2.00 x 120mm21”90

oceanus 14:

2.00 x 150mm5”01

Inflation & deflation time

oceanus 14 18 35

OCEANUS 14

PRODUCT 3mm atm FLUID TIME [s]

Sterling 14

Water 25ºC

3,02

Paseo-18 15 4,81

oceanus 18 16 2,13

PRODUCT 8mm atm FLUID TIME [s]

Sterling 12

Water 25ºC

4,71

oceanus 18 16 2,79

THE FASTEST


oceanus 14 18 35

OCEANUS 18

The catheter design optimizes balloon deflating lumen getting the

best speed of evacuation


oceanus 14 18 35

OCEANUS 35

oceanus 14

4 F

0.014

100 cm 40 60 80 120 150 200

1.5

2.0

2.5

3.0

3.5

4.0

150 cm 40 60 80 120 150 200

1.5

2.0

2.5

3.0

3.5

4.0

oceanus 14 18 35

0.018

100 cm20 40 60 80 120 150 200

2.0

2.5

3.0

3.5

4.0

5.0

6.0

7.0

8.0

oceanus 18

oceanus 14 18 35

140 cm 20 40 60 80 120 150 200

5.0

6.0

7.0

8.0

150 cm 20 40 60 80 120 150 200

2.0

2.5

3.0

3.5

4.0

oceanus 18

oceanus 14 18 35

oceanus 35

oceanus 14 18 35

0.035

80, 100 cm 40 60 80 120 150 200

3.0

4.0

5.0

6.0

7.0

8.0

9.0

10.0

12.0

5 F 6 F

PRECLINICAL DATA

• Healthy arteries, swine model

• Domestic pigs: 25 ± 3 kg; n = 17

− CoCr Stent: architect, n=51

− Post-dilatation Stent (balloon-artery ratio 1,21 ± 0,14) with:

Control: Bare balloon oceanus and xperience

DEB: luminor 14, luminor 35, essential 3 µg/mm2 paclitaxel,

Commercial DEB (In.Pact®): 3µg/mm2 paclitaxel, FreePac® tech

• 28-day follow-up: Angiography & Histology

− Restenosis: % diameter and area of stenosis, late-loss and neointimal area

− Vascular healing parameters: injury score, inflammation, fibrin and endothelization

TransferTech

Method

PRECLINICAL PORCINE MODEL: SAFETY, EFFICACY AND PHARMACOKINETICS

• >50% less restenosis than control

• 23% less restenosis than commercial DEB In.Pact

Efficacy: restenosis


• Inflamation is uniformly low in all groups

• Less endothelization and more fibrin than control pharmacological effect

• No differences between DEBs

Safety: vascular healing


• Inflammation is uniformly low in all groups

• Less endothelization and more fibrin than control pharmacological effect

• No differences between DEBs

• 3 extra pigs

• Sampling:

– n= 2, 15 - 30’

– n= 2, 60 - 90’

– n= 2, 120’

– n= 2, 24h

• HPLC analysis of µg paclitaxel / g tissue

Pharmacokinetics


Publications: Spanish Journal of Cardiology


CLINICAL DATA

Clinical Trial Product End dateEnrolled

patients

Total

patients

%enrolled

patientsExpected presentations at congresses

Last update: DEC 4th

Clinical Data: summary

LUMINOR

REGISTRY

luminor

14/35Jul 2017 219 > 200 100%

• LINC 2016; poster interim data 6M- secondary endpoint

• APR 2016: interim data published in “Técnicas

Endovasculares”

• SEP 2016: publication interim 12-M in “Angiology Journal”

• CIRSE 2016: interim data 12M- primary endpoint

• JAN 2017: Publication in Angiology of 12M interim analysis

• LINC 2017: interim data 12M- primary endpoint

• JUL 2017: Publication final results 12M “Annals of Vascular

Surgery” or “JEVT”

EFFPAC luminor 35 Jul 2017 162 172 94%

• LINC 2016: update study design presentation

• LINC 2017: 6-month interim results

• Final data: JUL 2017 (CIRSE & TCT 2017)

Clinical Data: summary

STUDY PRODUCT STUDY TYPEPATIENT/INJURY

TYPECENTERS COUNTRIES PATIENTS

PRIMARY

ENDPOINTSECONDARY ENDPOINT

LUMINOR

REGISTRY

DEB

luminor 14

luminor 35

Multicentric

prospective

registry

SFA

Popliteal artery

Tibial artery

10

Spain

(Dr. Acín, Dr.

Riambau)

250

Primary

Patency- 12M

MAE- 12M

Clinical success- 12M

Hemodynamical success- 12M

Quality of Life

EFFPAC

DEB vs

POBA

luminor 35

oceanus 35

Randomized

multicentric

prospective

study

SFA 11

Germany

(Dr. Scheinert,

Dr. Zeller,

Dr.Sixt,

Dr, Treitl)

172 LLL- 6MTLR- 6M/12M

MACE- 6M/12M

PMS luminor

angiolite

Prospective

registry

SFA

BTK- - All comers

Primary

Patency-

12M/24M

MAE- 12M/24M

Clinical success- 12M/24M

• LUMINOR DRUG ELUTING BALLOON

L U M I N O R r e g i s t r y

Performance of luminor drug eluting balloon for revascularization in chronic limb ischemia: a Spanish prospective multicentre registry.

F. Acín, M. de Blas, M. Alonso, A. Giménez-Gaibar, V. Riambau, on behalf of the LUMINOR Registry collaborators.

Clinical trials.gov identifier: NCT02458911

Background

Luminor is a new drug-coated angioplasty balloon from iVascular (CE-marked), with the unique TransferTech®technology that provides a durable crystalline coating.

Fig. 1 Macroscopic aspect of Luminor DCBs with an uniformcoating (A) in comparison with a competitor (B)

Fig. 2 Microscopic Cristalline structure of Paclitaxel coating (A) and ultrasoniccoating technology by nanodrops (B)


A

B A B

http://www.google.es/url?sa=i&rct=j&q=water+drops&source=images&cd=&cad=rja&docid=kxWww_lxBbXeEM&tbnid=wVofWEhZvC4rdM:&ved=0CAUQjRw&url=http://www.wallpaperdev.com/wallpaper/1680x1050/tiny-water-drops-wallpaper-by-kingl-57015.html&ei=1_t4UYSVFsSq0QWp4oCYDQ&bvm=bv.45645796,d.ZG4&psig=AFQjCNE5YVsH_wwT5emOLPD0N2g60JOXsw&ust=1366969525711633

Material and Methods

Luminor Registry is an observational, prospective, multicenter study with single-arm treatment forstenotic or occlusive lesions or in-stent stenosis of the femoro-popliteal (FP) and below the knee (BTK)vessels.

PRIMARY ENDPOINTSTo analyse the performance of Luminor 14 and 35 in terms of primary patency, defined as freedomfrom >50% restenosis as indicated by duplex ultrasound peak systolic velocity ratio (PSVR) <3 in thetarget vessel with no re-intervention, and freedom of serious adverse events defined as death,amputation and TLR during a minimum of 12-month follow-up period.

SECONDARY ENDPOINTSInclude quality of life assessment and other clinical or hemodynamic complications.


A total of 219 validated Rutherford 2-5 cases have been recruited during a 15-month period following anintention to treat basis. All the procedures have followed the instructions for use. Primary stenting oratherectomy are excluded. Adjuvant drug treatment is recommended for all patients [Clopidogrel 75mgr/day + ASA 100 mgr/day (one month) and ASA 100 mgr/day (indefinite)].

Material and Methods


Results


Table 1. Baseline DemographicsPatients %

Patients

Lesions

Male

Age, years

Diabetes

Smoking and ex-smoking

Arterial Hypertension

Hyperlipidemia

Chronic Renal Failure

Rutherford Class

2

3

4

5

215

252

72,6%

70,6±11,7

65,1%

63,3%

81,4%

57,7%

23,7%

6,1%

22,1%

11,7%

60,1%

156

140

136

175

124

51

13

47

25

128

Since Q3 2014 until Q2 2016, 215 cases with 252 lesions(121 CTO and 131 stenosis) have been included andmonitored (Table 1). Those were split as 154 FP and 86 BTKvessels treated. 12 cases combined both segments (Table2). It is important to emphasize that 72% of patients wereclassified as Rutherford 4 or 5 (Table 1). Technical successwas achieved in 94,9% of the cases. Bailout stenting wasnecessary in 15 lesions (6%).

Table 2. Lesion Characteristics

Lesion length (mm)

Chronic Total Occlusions

Stenosis

Target Vessels

Femoropopliteal

Below the Knee

Combined segments

77,8 (20-200)

48,0%

52,0%

61,2%

34,2%

4,6%

Results

30-day-mortality was 1,9%. Until now, 145 patients havereached 6 months of follow-up and 108 patients 1 year.

At 1 year, primary patency was 94,0%, freedom fromTLR 96,2%, freedom from amputation 89,8% andsurvival 90,4%.


Table 3. Main interim results

30-Days follow-up (211 patients)

All-cause mortality

Major amputations

TLR

1,9%

1,9%

1,4%

%

Conclusions

LUMINOR Spanish registry will publish further results in future reports.

Initial primary endpoints are encouraging taking into account the ischemic status severity of this cohort of patients.


EffPac trialEffectiveness of Paclitaxel

coated balloon luminor®


OBJECTIVESafety and efficacy of the luminor paclitaxel drug-eluting balloon in inhibiting

restenosis and in ensuring long-term patency

DISEASE UNDER

STUDYStenotic or occlusive lesions (length: >5 up and <15 cm) in the SFA

DEVICE luminor 35

PI Prof. Dr. Ulf Teichgräber, Jena University Hospital

DESIGN Investigator initiated, prospective, multi-centre trial and 2 arms randomised study

Phase III Multicenter Randomized Controlled Trial to Assess the Effectiveness of

Paclitaxel-coated Luminor® Balloon Catheter versus Uncoated Balloon Catheter in the

Superficial Femoral and Popliteal Arteries to Prevent Vessel Restenosis or Reocclusion

PATIENTS 172 FOLLOW UP 6 and 12 months

EffPacOverview


EffPacParticipating sites


PRIMARY ENDPOINTLate lumen loss (LLL) defined as difference between the diameters (in mm) at

6 months follow-up minus post-procedure

SECONDARY ENDPOINT

- Occurrence of restenosis defined as incidence of restenosis ≥50%

- Freedom from Target lesion / vessel revascularization (TLR and TVR)

- Rutherford stage @ 6M and 12M

- Ankle‐brachial index (ABI) @ 6M and 12M

- Walking distance to baseline @ 6M and 12M

- “Quality of Life” according to the WiQ and EQ5D @ 6M and 12M

EffPacEndpoint


Thank you!

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