luminor 14 18 35 - limit · pdf fileluminor 14 18 35. inhibition of ... eurocor freeway 014 -...
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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
LUMINOR DRUG ELUTING BALLOON
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
LUMINOR DRUG ELUTING BALLOON
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
LUMINOR DRUG ELUTING BALLOON
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
LUMINOR DRUG ELUTING BALLOON
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.
LUMINOR DRUG ELUTING BALLOON
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
LUMINOR DRUG ELUTING BALLOON
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
LUMINOR DRUG ELUTING BALLOON
5. Coating strategy
Crystalline Amorphous
Particle release
Coating uniformity
Drug-vessel transfer
Drug retention vs time
Biological effectiveness
crystalline
LUMINOR DRUG ELUTING BALLOON
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
LUMINOR DRUG ELUTING BALLOON
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
LUMINOR DRUG ELUTING BALLOON
7. Coating technology
TransferTechluminor
IN.PACT Admiral
LUMINOR DRUG ELUTING BALLOON
7. Coating technology
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
LUMINOR DRUG ELUTING BALLOON
7. Coating technology
LUMINOR DRUG ELUTING BALLOON
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
LUMINOR DRUG ELUTING BALLOON
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
LUMINOR DRUG ELUTING BALLOON
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
LUMINOR DRUG ELUTING BALLOON
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
LUMINOR DRUG ELUTING BALLOON
Sizes: luminor 14
4 F
LUMINOR DRUG ELUTING BALLOON
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
The platform: luminor 18 >> oceanus 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”
The platform: luminor 35 >> oceanus 35
LUMINOR DRUG ELUTING BALLOON
Sizes: luminor 35
5 F
LUMINOR DRUG ELUTING BALLOON
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
LUMINOR DRUG ELUTING BALLOON
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
Pushability & trackability: structure
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
Pushability & trackability: structure
oceanus 14 18 35
OCEANUS 35
1. Pushability and trackability
• Structure (flexibility)
• Hydrophilic Coating
• Radiopaque Markers
Technical features: pushability & trackability
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
1. Pushability and trackability
• Structure (flexibility)
• Hydrophilic Coating
• Radiopaque Markers
Technical features: pushability & trackability
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
1. Pushability / Trackability
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
Product profile- entry: tip
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
Product profile- entry: tip
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
Crossing profile: tip- balloon welding
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
Crossing profile: tip- balloon welding
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
Crossing profile: folding-refolding
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
Crossing profile: folding-refolding
oceanus 14 18 35
OCEANUS 18
1. Pushability / Trackability
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
Inflation & deflation time
oceanus 14 18 35
OCEANUS 18
The catheter design optimizes balloon deflating lumen getting the
best speed of evacuation
Inflation & deflation time
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
PRECLINICAL PORCINE MODEL: SAFETY, EFFICACY AND PHARMACOKINETICS
• Inflamation is uniformly low in all groups
• Less endothelization and more fibrin than control pharmacological effect
• No differences between DEBs
Safety: vascular healing
PRECLINICAL PORCINE MODEL: SAFETY, EFFICACY AND PHARMACOKINETICS
• 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
PRECLINICAL PORCINE MODEL: SAFETY, EFFICACY AND PHARMACOKINETICS
Publications: Spanish Journal of Cardiology
PRECLINICAL PORCINE MODEL: SAFETY, EFFICACY AND PHARMACOKINETICS
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)
L U M I N O R r e g i s t r y
A
B A B
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.
L U M I N O R r e g i s t r y
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
L U M I N O R r e g i s t r y
Results
L U M I N O R r e g i s t r y
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%.
L U M I N O R r e g i s t r y
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.
L U M I N O R r e g i s t r y
EffPac trialEffectiveness of Paclitaxel
coated balloon luminor®
LUMINOR DRUG ELUTING BALLOON
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
LUMINOR DRUG ELUTING BALLOON
EffPacParticipating sites
LUMINOR DRUG ELUTING BALLOON
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
LUMINOR DRUG ELUTING BALLOON
Thank you!