Medtronic In.Pact Clinical Evidence

IN.PACT DEB

IN.PACT DEB Technology
TECHNOLOGY

IN.PACT DEB
Technology and CLINICAL TRIAL
Clinical Evidence OVERVIEW

Clinical Trial Overview
SFA
RESULTS

SFA Results
BTK
RESULTS

BtK Results
Order information & Abbreviations

ORDER
INFORMATION
& ABBREVATIONS

IN.PACT DEB

TECHNOLOGY

4 DEB Components

IN.PACT DEB
FreePac Coating Technology

How to use a DEB


SFA
RESULTS

SFA Results
BTK
RESULTS

BtK Results

ORDER
INFORMATION
& ABBREVATIONS

TECHNOLOGY

IN.PACT
PACLITAXELELUTING BALLOONS

IN.PAC T DEB TECHNOLOGY
4 DEB components interweaving towards performance...

MEDTRONIC INVATEC
1. PLATFORM proven PTA full balloon line

SFA Results
PACLITAXEL
2. DRUG hydrophobic, lipophilic,
proven antiproliferative drug

UREA
3. EXCIPIENT hydrophilic,
non toxic

MEDTRONIC INVATEC

BtK Results
©2011 Medtronic, Inc. All Rights Reserved. Printed in EU. Not for distribution in the USA. 0170631, 01/12

4. COATING TECH uniformity + stability + release
controlled and scaleable

IN.PACT Admiral IN.PACT Pacific IN.PACT Amphirion
Paclitaxel-Eluting Paclitaxel-Eluting Paclitaxel-Eluting
PTA Balloon Catheter 0.035" PTA Balloon Catheter 0.018" PTA Balloon Catheter 0.014”

TECHNOLOGY

IN.PACT

IN.PACT DEB TECHNOLOGY

IN.PACT™ DEB WITH FREEPAC™ COATING TECHNOLOGY

IN.PACT™
Medtronic Invatec DEB balloon line
FREEPAC™
Proprietary hydrophilic coating formulation
– Urea separates Paclitaxel molecules
– Increased drug solubility and optimal diffusion
into vessel wall
– Urea facilitates Paclitaxel absorption into the vessel wall

SFA Results
PACLITAXEL - proven antiproliferative

UREA - natural and hydrophilic excipient

BtK Results
IN.PACT Paclitaxel elution timeline
10 SECONDS 15 SECONDS 60 SECONDS Order information & Abbreviations

WRAPPED BALLOON FOLDS UNWRAPPING BALLOON INFLATED AND ELUTING ELUTION DRUG UPTAKE
The IN.PACT DEB is The balloon unwraps to Urea molecules facilitate carriage Drug elution takes place COMPLETED
delivered to the target site expose the FreePac coating of paclitaxel molecules across the within 30 - 60 seconds
vessel wall

www.medtronic.com Global Headquarters
www.invatec.com Hungerbüelstrasse 12
8500 Frauenfeld – Switzerland

TECHNOLOGY

IN.PACT

IN.PACT DEB TECHNOLOGY

HOW TO USE DRUG ELUTING BALLOONS

FOLDED BALLOON HANDLE WITH CARE
• DEB surface can be touched and handled gently
Handle with care • Do not rub the coated balloon
• Do not use any protective / insertion sheath to
advance the DEB trough the introducer sheath
and/or hemostatic valve
1. Lesion
PRE-DILATATION RECOMMENDED
IN CERTAIN CASES

SFA Results
2. Pre-dilatation
• For pre-dilatation in case of total occlusions
or sub-occlusive lesions use a standard balloon
3. DEB (approx. 0.5 mm smaller than RVD)
• Choose a DEB with a nominal size equal
to reference diameter

DRUG RELEASE WITHIN
30 - 60 SECONDS
• Longer inflation times are possible at
discre t ion of operator - to pursue optimal
Duration time 30 - 60 sec.
mechanical dilatation - but do not lead to
further drug release

BtK Results
ONE DRUG-ELUTING BALLOON
Lesion 1, DEB 1 Lesion 2, DEB 2 FOR EACH LESION
• For single use only, drug is released upon
the first inflation
• In longer lesions DEB overlapping is indicated

overlap overlap
IF A STENT IS PRESENT AN OVERLAP
WITH DEB IS RECOMMENDED

8500 Frauenfeld – Switzerland

IN.PACT DEB

TECHNOLOGY

IN.PACT DEB

IN.PACT Clinical Trial Program

SFA
RESULTS

SFA Results
BTK
RESULTS

BtK Results

ORDER
INFORMATION
& ABBREVATIONS

OVERVIEW

IN.PAC T CLINICAL
TRIAL PROGRAM
16 Clinical Trials / 10 RCT / 113 Clinical Sites / 2.020 patients

Primary
Indication Design # Sites Arms Endpoint Pl(s) #Pts

SFA
IN.PACT SFA I SFA de-novo RCT 10 DEB vs PTA + 12m Prim. G. Tepe 150
prov Stent Patency
IN.PACT SFA II SFA de-novo RCT 50 DEB vs PTA + 12m Prim. P. Schneider, 280
prov Stent Patency J. Laird
DEB SFA IT Registry* SFA de-novo Registry 6 DEB + prov 6m Patency A. Micari 105
Stent
PACIFIER* SFA de-novo RCT 3 DEB vs PTA + 6m LLL M. Werk 91
prov Stent
ISAR-STATH* SFA de-novo RCT 2 DEB + Stent vs 6m %DS I. Ott, 150
Stent vs Ather. M. Fusaro
IN.PACT CALCIUM* SFA de-novo Registry 1 Atherectomy 12m RR (DUS) A. Cioppa 20

SFA Results
Ca++ + DEB

SFA-ISR
PHOTOPAC* SFA ISR RCT 3 Laser + DEB vs 12m %DS T. Zeller 50
DEB alone
FAIR* SFA ISR RCT 3 DEB vs PTA 6m DUS re- H. Kranken- 118
restenosis berg
ISAR PEBIS* SFA ISR RCT 1 DEB vs PTA 6m %DS I. Ott, 70
M. Fusaro
FRENCH SFA Registry* SFA ISR Registry 13 DEB 12m TLR Y. Gouëffic 100

SFA & BTK
DEBELLUM* SFA BTK RCT 1 DEB vs PTA 6m LLL F. Fanelli 50

BtK Results
BTK
DEB BTK IT Registry* BTK de-novo Registry 6 DEB + prov 6m RR (Angio) G. Biamino 100
Stent
IN.PACT BTK Abano* BTK de-novo Registry 1 DEB + prov 6m RR (Angio) M. Manzi 122
Stent
IN.PACT BTK DEB BTK de-novo Registry 1 DEB + prov 3m RR (Angio) D. Scheinert 107
Leipzig Registry* Stent
IN.PACT DEEP BTK / CLI RCT 11 DEB vs PTA + 12m LLL + TLR I. Baumgart- 357

de-novo prov Stent + 6m Events ner, T. Zeller,
D. Scheinert
DEBATE* BTK/CLI/ RCT 1 DEB vs PTA + 12m Angio RR F. Liistro 150
Diabetics prov Stent

* Physician sponsored
STATUS DATE: 01/2012

IN.PACT DEB

TECHNOLOGY

IN.PACT DEB

SFA
RESULTS

SFA Results
Italian SFA Registry

SFA Trial PACIFIER

SFA Trial DEBELLUM

BTK
RESULTS

BtK Results

ORDER
INFORMATION
& ABBREVATIONS

SFA

CAS, Supraortic
DE-NOVO

IN.PACT Admiral
PACLITAXELELUTING PTA BALLOON CATHETER 0.035"

DRUG-ELUTING BALLOONS FOR LOWER LIMB ARTERIAL DISEASE

DEB SFA

ITALIAN REGISTRY*
IN.PACT drug-eluting balloon demonstrates
high primary patency with low stent rate
Data presented at PCR 2011 by Dr. Micari

REGISTRY PURPOSE
To assess the benefit of DEB usage within standard practice for the treatment of
femoro-popliteal arterial disease in patients with claudication and rest pain

SFA Results
PRIMARY ENDPOINT
The primary endpoint was primary patency at 12 months

STUDY METHODS
- Investigator sponsored multi-center observational registry
- Predilatation with conventional undersized PTA balloon, DEB dilatation for 180 sec
- Provisional stenting in case of flow limiting dissections and persistent residual
stenosis > 50%

BtK Results
PATIENT DEMOGRAPHICS

(105 PATIENTS, AGE 68 ± 9)
Hypertension 90 (85.7%)
DEB SFA
Hyperlipidaemia ITALIAN REGISTRY
78 (74.3%)
Diabetes 51 (48.6%) * Micari et al., EuroIntervention Volume 7,
Insul. dependant 23 (45.1%) Supplement K, May 2011, A new paclitaxel-
eluting balloon for angioplasty of femoro-

Renal insufficiency 2 (1.9%) popliteal obstructions: acute and midterm
results
Smoking 66 (62,8%)
Coronary Artery Dis. 45 (42.9%)
Carotid Artery Dis. 15 (14.3%)

10 20 30 40 50 60 70 80 90 100
Average Lesion Length: 76mm. Total Occlusions: 29.8%. ABI 0.56 ± 0.15
Rutherford Class II 26,7%, Rutherford Class III 64,8%, Rutherford Class IV 7.6%


SFA
DE-NOVO

IN.PACT Admiral
PACLITAXELELUTING PTA BALLOON CATHETER 0.035”

DEB SFA ITALIAN REGISTRY IN.PACT drug-eluting balloon

demonstrates high primary

PTA Balloon Catheter
patency with low stent rate

ACUTE OUTCOME
Pre-dilatation · · · · · · · · · · · · · · · · · · · · · · 113 (99.1%)

DEB inflation time · · · · · · · · · · · · · · · · · · · · · · 181 ± 20.4 sec

No DEB p/lesion · · · · · · · · · · · · · · · · · · · · · · 135/114 = 1.18

Device Success · · · · · · · · · · · · · · · · · · · · · · 135 (100%)

Tech. Success · · · · · · · · · · · · · · · · · · · · · · 121 (89.6%)

SFA Results
Stenting · · · · · · · · · · · · · · · · · · · · · · 14 (12.3%)

12 MONTHS RESULTS
– Primary Patency 83.7%
– TLR rate 8.7% 100%
90%
– ABI, Quality of Live, 80%
Walking capacity, 70% 12M Survival from TLR, Occlusion, >50% Restenosis
60% Primary Patency 83.7%
Rutherford class 50%
improvements 40%
30% PSVR <2.5
20%

BtK Results
10%
days after
procedure 0 180 360

REGISTRY CONCLUSION & DISCUSSION
– High primary patency rate and low TLR rate despite conservative usage of stents
– Clinical benefit is consistently shown across multiple endpoints

Patency rates are in line with previously reported results of Drug Eluting Balloons
(Thunder, Fempac)**

** Tepe et al., N Engl J Med 2008; 358:2406-2407 / Werk et al.,
Circulation. 2008; 118: 1358-1365

8500 Frauenfeld – Switzerland STATUS DATE: 02/2012

SFA
DE-NOVO

IN.PACT Paciﬁc


SFA TRIAL  PACIFIER

IN.PACT drug eluting balloon superior to PTA with
regards to 6 months Late Lumen Loss
Data presented at LINC 2012 by Dr. Werk

STUDY PURPOSE
To demonstrate efficacy of the paclitaxel eluting balloon to inhibit restenosis of
femoropopliteal stenosis and occlusions vs. standard PTA

SFA Systems
Stent Results
PRIMARY AND SECONDARY ENDPOINTS
- The primary endpoint was Late Lumen Loss (LLL) at 6 months
- Secondary endpoints: 6-m binary restenosis rate, 6-m TLR, 6-m RC change,
6-m event free survival

STUDY METHODS
- Investigator sponsored multi-center randomized (1:1) trial
- Independent, blinded Angiographic Corelab
- Provisional stenting in case of flow limiting dissection or persistent residual stenosis

BtK Results
PATIENT DEMOGRAPHICS AND LESION CHARACTERISTICS

DEB Control THE PACIFIER TRIAL
No. of Patients n 44 47
* A Randomized Multicenter Trial Evaluating
Mean Age y ± SD 71 ± 7 71 ± 9 Prevention of Restenosis with Paclitaxel-
Coated PTA Balloon Catheters in Stenosis or
Diabetes n (%) 19 (43%) 13 (28%) Occlusion of Femoropopliteal Arteries
Hypertension n (%) 29 (66%) 31 (66%)
M. Werk, T. Albrecht, D.-R. Meyer, H. Stiepani,
Hypercholesterolemia n (%) 22 (50%) 22 (47%) B. Schnorr, U. Dietz, E. Lopez Hänninen
ABI mean ± SD 0.73 ± 0.30 0.65 ± 0.26

Departments of Radiology of the Martin-
95% of patients were in Rutherford Luther-Hospital, Hubertus-Hospital, Vivantes
Klinikum Neukölln, Berlin, Germany
classes 2 or 3 at baseline.
Avg lesion length cm ± SD 7.0 ± 5.3 6.6 ± 5.5 presented at LINC 2012

Ref. Vessel Diameter mm 4.92 4.90
% Diameter Stenosis (%) 73% 80%
Total Occlusions n (%) 10 (23%) 18 (38%)
68% (DEB arm) were de-novo lesions, but also
restenotic and ISR was included in the protocol.


SFA
DE-NOVO

IN.PACT Paciﬁc

SFA TRIAL  PACIFIER IN.PACT drug eluting balloon superior

to PTA with regards to 6 months Late
Lumen Loss

ACUTE OUTCOME
DEB Control P value
Pre-Dilatation n (%) 6 (13.6%) 3 (6.4%) 0.30
Balloon inflation time mean ± SD 76 ± 33 sec 76 ± 25 sec 0.89
Dissections n (%) 18 (41%) 25 (53%) 0.48
Provisional Stent Rate n (%) 9 (21%) 16 (34%) 0.17
Residual Stenosis mean±SD 12±12% 11±12% 0.5

6 MONTHS RESULTS (ANGIOGRAPHIC AND CLINICAL)

SFA Results
DEB Control P value
% Diameter Stenosis % 29.7% 39.4% 0.05
Min. Lumen Diameter mm 3.61 2.94 0.0014
Binary Restenosis n/N (%) 3/35 (8.6%) 11/34 (32.4%) 0.01
Late Lumen Loss mm -0.01 0.65 0.0014

6M MAJOR p=0.04
ADVERSE EVENTS 30% –
p=0.12 26.2%
25% –
21.4%
DEB 20% –

Control 15% –

10% –

BtK Results
7.1% 7.1%

Go Deep
4.8%
5% –
0% – 0.0% 0.0% 0.0%

TLR Amputation Death Composite

CONCLUSION
IN.PACT PACIFIC™ confirms to effectively reduce neointima hyperplasia in SFA with
a significant decrease in LLL at 6 months vs standard PTA
Clinical Events (Secondary Endpoints) trend / are in favor of DEB

No coating related adverse events noted


SFA/BTK

IN.PACT Admiral

IN.PACT Amphirion


DEBELLUM: Drug Eluting Balloon

Evaluation for Lower Limb mUltilevel treatMent*
IN.PACT drug eluting balloon superior to PTA with regards
to 6 months Late Lumen Loss
Data presented at MEET 2011 by Dr. F. Fanelli

STUDY PURPOSE
To assess the effect of DEB for multilevel lower limb revascularization compared to PTA

PRIMARY AND SECONDARY ENDPOINTS

SFA Results
- The primary endpoint was Late Lumen Loss (LLL) at 6 months (US evaluation)
- Secondary endpoints: Target Lesion Revascularization, Thrombosis and Amputation

STUDY METHODS
– Investigator sponsored single-center randomized (1:1) trial
– Provisional Stenting in case of flow limiting dissection or persistent residual stenosis
– Study devices: IN.PACT Amphirion (BtK) and IN.PACT Admiral (SFA)

STUDY DESIGN N= 50 PTS. PRIMARY ENDPOINT: LATE LUMEN LOSS AT 6 MONTHS

BtK Results
DEB
N= 25 pts | 57 lesions N= 25 PTS | 65 LESIONS
Uncoated balloons
Native Stenosis Stenting Native Stenosis Stenting
(26 lesions) (31 lesions) (30 lesions) (35 lesions)

PATIENT DEMOGRAPHICS AND LESION CHARACTERISTICS

Patient Lesion DEBELLUM
Drug-Eluting Abbreviations

Demographics Characteristics
* Dr. Fabrizio Fanelli
Patients n 50 Overall Lesions 122 Vascular and Interventional Radiology Unit
Department of Radiological Sciences
Order information &Balloons

Age y 67 ± 21 Femoro-Popliteal Lesions 92 (76%) “Sapienza” - University of Rome
Diabetes 22 (45%) BtK Lesions 30 (24%)
presented at MEET 2011
High Cholesterol 29 (59%) Mean Lesion Length (cm) 7.5 ± 3.5
Hypertension 34 (68%) % Stenosis
85 ± 6.4
ABI 0.53 ± 0.18 Diameter
Total Occlusion 26 (22%)
Fontaine Stage 2b 31 (62%)
Fontaine Stage 3 14 (28%)
Fontaine Stage 4 5 (10%)

SFA/BTK

IN.PACT Admiral

IN.PACT Amphirion


DEBELLUM: Drug Eluting Balloon IN.PACT drug eluting balloon

superior to PTA with regards to
6 months Late Lumen Loss

Evaluation for Lower Limb mUltilevel treatMent

6 MONTHS RESULTS (ANGIOGRAPHIC AND CLINICAL)
Overall analysis: 0.5±1.4mm (DEB) vs 1.6±1.7mm (PTA). P<0.01
Native stenosis analysis: 0.5mm (DEB) vs 1.5mm (PTA. P<0.01
Stent analysis: 0.51mm (DEB) vs 1.7mm (PTA). P<0.01

6 MONTHS SUBANALYSIS

2.0 mm –
1.7
1.6 1.5
1.5 mm –

SFA Results
DEB
1.0 mm –
PTA 0.5 0.5 0.51
0.5 mm –
0 mm –
Overall values Native Stenosis Stent Analysis
Analysis

SECONDARY ENDPOINTS
TLR clinically and diagnostic 40% – 36
(USCD or DSA) driven 30% – DEB
25% – PTA
20% –

BtK Results
15% –
12
10% – 8 7 8

5% – 3

0% –
TLR Thrombosis Amputation

CONCLUSION

Drug eluting balloons are safe and effective for the inhibition of neointimal hyperplasia
No significative different results between native stenosis and post-stents dilatation
Six-months follow-up showed lower neointimal hyperplasia, lower TLR rates and better
clinical outcomes in the DEB group compared with the non-coated balloon group.*

* the study was not powered against secondary endpoints.


IN.PACT DEB

TECHNOLOGY

IN.PACT DEB

SFA
RESULTS

SFA Results
BTK
RESULTS

BtK Results
BtK DEB Leipzig Registry

DEBATE-BtK Order information & Abbreviations

ORDER
INFORMATION
& ABBREVATIONS

BTK
DE-NOVO

IN.PACT Amphirion

BTK DEB LEIPZIG

REGISTRY
IN.PACT drug eluting balloon reduces early restenosis
and TLR Rate of long BtK lesions

REGISTRY PURPOSE
The purpose of this study was to investigate the efficacy of drug-eluting balloons
(DEBs) in the treatment of long infrapopliteal lesions with regard to the short-term

SFA Results
restenosis rate and midterm clinical result.

PRIMARY ENDPOINT
The primary endpoint was the angiographic binary restenosis.

STUDY METHODS
Infrapopliteal angioplasty was performed with an IN.PACT AMPHIRION paclitaxel-eluting
balloon clinical and angiographic follow-up was performed at 3 months to detect bina-
ry restenosis, and further clinical assessment was performed over a 12-month period.

Btk Results
PATIENT DEMOGRAPHICS
(104 Patients, Age 73.6 ± 6.7, Male 69 =66.3%)

Arterial hypertension 95 (91.3%) BTK REGISTRY
Diabetes mellitus 74 (71.1%)
Smoking habit 32 (30.8%) * Schmidt et al. J Am Coll Cardiol.2011; 58: 1105-
Hypercholesterolemia 1109
68 (65.4%)

** Schmidt et al. Catheterization and Cardiovas-
Obesity 33 (31.7%) cular Interventions, 76: 1047–1054
Coronary artery disease 47 (45.9%)
NYHA functional classes III and IV 23 (22.1%) A. Schmidt, MD
Center of Vascular Medicine Angiolo-
Renal insufficiency (GFR 60 ml/min/1.73 m2) 48 (46.2%) gy, Cardiology and Vascular Surgery
Cerebrovascular disease 19 (18.3%) Park Hospital Leipzig, Germany

10 20 30 40 50 60 70 80 90 100


BTK
DE-NOVO

IN.PACT Amphirion

BTK DEB LEIPZIG REGISTRY IN.PACT drug eluting balloon reduces early

restenosis and TLR Rate of long BtK lesions

ANGIOGRAPHIC RESULTS
Mean infrapopliteal lesion length was 17.6mm. Angiography at 3 months found 72.6% of all
arteries free of significant restenosis.
Rate of completely occluded arteries · · · · · · · · · · · · · · · · · · · · · · · · · 9.5%
Binary restenosis rate at 3 months · · · · · · · · · · · · · · · · · · · · · · · · · 27.4%

3 MONTHS ANGIOGRAPHIC Distal popliteal 1 (9.1%)
RESTENOSIS RATE BY VESSEL DISTRICT Anterior tibial artery 15 (31.3%)
(104 PATIENTS, AGE 73.6 ± 6.7) Tibioperone al trunk 3 (16.7%)
Posterior tibial artery 5 (31.3%)
Peronal artery 3 (16.7%)
Proximal segment of tibial arteries 5 (9.3%)
Mid segment of tibial arteries 9 (20.0%)

SFA Results
Distal segment of tibial arteries 7 (18.9%)
Arteries distal to the malleolus 5 (38.5%)

5 10 15 20 25 30 35 40

CLINICAL RESULTS Favourable clinical results and a limb salvage rate of 95.4%

TLR at 12 months · · · · · · · · · · · · · · · · · · · · · · · · · 17.4%
Clinical improvement · · · · · · · · · · · · · · · · · · · · · · · · · 95.6%
Complete wound healing · · · · · · · · · · · · · · · · · · · · · · · · · 74.2%
RUTHERFORD SHIFT (12.5 MONTHS) 70 baseline
Numbers of limbs

70 (64.2%)

60
19 (17.45%)

19 (17.45%)

mid-term FU
50
40

Btk Results

30
1 (0.9%)

20
10
0
Rutherford-Becker categories 0 1 2 3 4 5 6

REGISTRY CONCLUSION & DISCUSSION
The early restenosis rate of long-segment infrapopliteal disease is significantly lower
after treatment with DEBs compared with historical data using uncoated balloons.

A historical control group** with similar patients showed 69% binary restenosis rate at
3 months, 56% restenosis of the whole segment and a TLR rate of 50% at 15 months.
DEB resulted in better restenosis rate at 3 months, lower rate of totally occluded arte-
ries and lower TLR rates.


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