1. The Invatec Program Features and Clinical Trials
Bruno Scheller, MD
Klinische und Experimentelle Interventionelle Kardiologie,
Universität des Saarlandes, Campus Homburg
Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes
Homburg / Saar, Germany

2. Bruno Scheller, MD, PhD DISCLOSURES Honoraria
B. Braun Vascular Systems, Invatec SRL
Grants/Contracted Research
B. Braun Vascular Systems
Ownership Interest (Stocks, Stock Options or Other Ownership Interest)
InnoRa GmbH
I intend to reference unlabeled/ unapproved uses of drugs or devices in my presentation.
I intend to reference Drug Eluting Ballon, CE-approved but not FDA-approved.

3. Conflict of Interest Affiliation/Financial Relationship Company
Grant/Research Support B.Braun Vascular Systems, Berlin, Germany
Speaker Honoraria B.Braun Vascular Systems, Berlin, Germany
Invatec Technology Center GmbH, Frauenfeld, Switzerland
Ownership, Shareholder InnoRa GmbH, Berlin, Germany

4. Drug Coated Balloon Drug Eluting Stent Drug Coated Balloon
Slow release
Persistent exposure
~ µg dose
Polymer
Stent mandatory
Drug Coated Balloon
Immediate release
Short-lasting exposure
~ µg dose
No polymers
Premounted stent optional
Scheller, Circulation 2004; 110: 810-4
Scheller, Heart 2007, 93:

5. DEB + stent - porcine coronary model
EEE Paclitaxel
Ac Paclitaxel Iopromide
Circulation 2004; 110: 810-4

6. Scheller, New Engl J Med 2006, 355: 2113-24
PaccocathTM
Scheller, New Engl J Med 2006, 355:
Tepe, N Engl J Med 2008; 358:

7. Waksman, Circ Cardiovasc Intervent. 2009; 2: 352-8

8. The Design Requirements for a Successful Drug Coated Balloon
Combination of Drug and Additive
Coating method (homogeneity, reproducibility)
Drug transfer to the tissue
Biological efficacy, dose dependency
Balloon inflation time, safety in overdosing
Clinical efficacy (reproducibility in RCT‘s and different indications)
So far, the only technology fulfilling all these requirements:
PACCOCATH®

9. Invatec DCB Program Four DCB platforms Coronary Peripheral
In.Pact Falcon, PTCA, 0.014“
Peripheral
In.Pact Pacific, PTA SFA, 0.018“
In.Pact Admiral, PTA SFA, 0.035“
In.Pact Amphirion, PTA BTK, 0.014“

10. Invatec FreePacTM DCB Technology
proprietary hydrophilic coating formulation
paclitaxel (3 μg/mm2 balloon surface)
urea
hydrophilic additive
natural degradation product of protein synthesized in the liver
one of the most common substances in human serum ( mg/liter)
low toxicity, no hypersensitivity reactions
undisclosed solvents

11. FreePac Pharmacokinetics Paclitaxel in coronary artery segments at various time points
B. Kelsch, submitted for publication

12. FreePac – Porcine Coronary Stent Model
Neointimal area 28 days
Control
(no drug)
FreePac™ coating
(3 μg paclitaxel/mm2)
Ac= Paccocath™ coating
B. Kelsch, submitted for publication

13. No aneurisms, even in the high dose groups!
Drug Coated Balloon - Dose Finding Histomorphometry – Porcine Coronary Stent Model
No aneurisms, even in the high dose groups!
B. Kelsch, submitted for publication

14. Clinical Plan 2010 Study PI Indication type 1° Endpoint Status
IN.PACT CORO I
F.Burzotta
C.Trani
de-novo
PILOT 3 arm RCT
DCB pre- vs post-dilat vs BMS (30 pts)
6m neo-intimal area by OCT
Enrolment ongoing
BELLO
A.Colombo
A.Abizaid
small vessels
RCT multicenter EU DCB vs Taxus (182 pts)
6m LLL
Enrol start Q1 2010
IN.PACT CORO ISR
B.Scheller
ISR
Single arm single center (23 pts)
Enrolment completed
IN.PACT DEEP
I.Baumgarner
T.Zeller
D.Scheinert
BTK
(CLI)
RCT multicenter EU DCB vs PTA (357 pts)
12m LLL
12m TLR
IN.PACT BTK
Registry Leipzig
(CLI, Claudic.)
DCB vs PTA (100 pts)
6m Rest. Rate
FAIR
H.Krankenberg
SFA
(ISR)
RCT multicenter EU DCB vs PTA (118 pts)
IN.PACT SFA I
G.Tepe
(de-novo)
RCT multicenter EU
DCB vs PTA (120 pts)
6m MAE
12m Prim. Patency
Enrol start Q3 2010
IN.PACT SHUNT
P.Pattynama
Hemodialysis Shunts
RCT multicenter EU DCB vs PTA (136 pts)

15. In.Pact Falcon – treatment of ISR
ISR CX
In.Pact Falcon mm
Final result
6 months

16. IN.PACT BTK Registry Leipzig preliminary results (LINC 2010)
Prospective registry of patients with BTK-lesions
In.Pact Amphirion paclitaxel-coated balloon
Angiography after 3 months
Clinical FU 3, 6 and 12 months
102 pts. treated with In.Pact Amphirion
3 months FU available in 64 pts.
2 pts. died
1 cardiac death, 1 major amputation
15 pts. did not come to the 3-months FU
Schmidt A, LINC 2010

17. IN.PACT BTK Registry Leipzig preliminary results (LINC 2010)
Angiographic FU in 48 pts.
Diabetes mellitus 41 / 48 (85 %)
Lesions treated with In.Pact Amphirion
De-novo 28 (58 %)
Restenosis 15 (31 %)
In-stent restenosis 5 (11 %)
Mean lesion-length 170 ± 76 mm
Total occlusion 28 (58 %)
Schmidt A, LINC 2010

18. IN.PACT BTK Registry Leipzig preliminary results (LINC 2010)
Rutherford categories before and at 3 mo FU
Schmidt A, LINC 2010

19. IN.PACT BTK Registry Leipzig preliminary results (LINC 2010)
In.Pact Amphirion paclitaxel-coated balloon 3 months angio
Restenosis 15 / 48 (31 %)
focal restenosis 8 / 15 (53 %)
whole treated segment 7 / 15 (47 %)
Comparison with 3-months angio after POBA of long BTK-lesions
58 CLI-pts. / 62 limbs
mean length 183 mm
Restenosis after 3 months: 68.8 %
Schmidt A, LINC 2010

20. IN.PACT BTK Registry Leipzig preliminary results (LINC 2010)
Schmidt A, LINC 2010

21. The Invatec Drug Coated Balloon Program
DCB based on the PaccocathTM technology fulfill all requirements for a successful DCB (including positive RCT‘s)
Preclinical data show a similar biological response after experimental injury in the porcine model with the FreePacTM and PaccocathTM coating
Promising first clinical experience with the FreePacTM coating (coronary ISR and BTK)
RCT‘s are underway