1. V. Dorrucci (Venezia)

2. UNA REALTÀ ITALIANA GUIDATA DALLA TECNOLOGIA.
DISPOSITIVI INNOVATIVI SVILUPPATI PER OTTIMIZZARE L'EFFICACIA E LA SICUREZZA:
UNA REALTÀ ITALIANA GUIDATA DALLA TECNOLOGIA.
Vittorio Dorrucci
Azienda ULSS 12 Veneziana S.C. di Chirurgia Vascolare ed Endovascolare
Dipartimento CardioToracoVascolare Direttore: Dr Vittorio Dorrucci

3. Carbon exists in 4 forms : diamond, graphite, glassy carbon, pyrolytic carbon (the only one used as a coating).
CID has developed Bio-Inducer Surface
Diamond – like carbon coating

4. “Physical and mechanical properties derive from richness in sp3 bonds”
CID has developed Bio-Inducer Surface: Getting a faster endothelialization
“Physical and mechanical properties derive from richness in sp3 bonds”
The nature of pure carbon coatings depends on their closeness to the molecular structure of diamonds (sp3 bonds)
The Bio Inducer Surface (≤0.3 µm) is a 2nd generation pure carbon coating that has a cristalline structure extremely close to that of diamond, with a further improvement of its bio/haemo compatibility

5. Pyrolytic Carbon FUNDAMENTAL CHARACTERISTICS
Biocompatibility (structure similar to the chemically inert diamond)
Thrombus resistance
Woven elasticity similar to bony
Good resistance to the friction
Good solidity

6. Pyrolytic Carbon
Biomaterials September 1995 (Vol. 16, Issue 13, Pages 973-6)
Platelet and coagulation factor variations induced in vitro by polyethylene terephthalate (Dacron) coated with pyrolytic carbon. E Cenni, C R Arciola, G Ciapetti, D Granchi, L Savarino, S Stea, D,etc
Biomaterials November 1995 (Vol. 16, Issue 16, Pages )
Adhesive protein expression on endothelial cells after contact in vitro with polyethylene terephthalate coated with pyrolytic carbon. E Cenni, D Granchi, C R Arciola, G Ciapetti, L Savarino, S Stea, D
Journal of Materials Science Volume 16, Number 12,
Nitinol Carbofilm coated stents for peripheral applications: Study in the porcine model
Prunotto M, Isaia C, Gatti MA
J Mater Sci Mater Med Dec;16(12):
Nitinol Carbofilm coated stents for peripheral applications: study in the porcine model.
Prunotto M, Isaia C, Gatti MA, Monari E, Pasquino E, Galloni M.

7. Carbofilm: Key Features
Enhance haemo and biocompatibility
Improve tissue interaction and inhibits foreign body reaction
Improve Blood Interaction:
preventing clot and thrombus formation
reducing local inflammatory reaction
promoting a well organized layer growth
improve surface endothelialization
Inhibits Complement activation

8. The worst setting for trombotic events
Sorin
Carbomedics
St. Jude
Medtronic
…others....
Pyrolitic Carbon (PyC) is the only material used to realize mechanical heart valve leaflets since almost 40 years thanks to its un-matched
thrombo-resistant properties

9. Carbofilm: Range of Application
CARBOSTENT 

10. Bio Inducer Surface Biocompatibility: In vivo evidence (1)
Balloon Expandable Stents

11. Bio Inducer Surface Biocompatibility: In vivo evidence (2)
Self Expanding Stents

12. Bio Inducer Surface is available on
the entire CID stent product portfolio

13. Self Expanding Stents Flexibility and Conformability for SFA
Cell design dedicated to SFA guarantees appropriate flexibility for optimal conformability 
Adequate Radial Force for high-calcified vessels
Lengths up to 150 mm to treat long lesions
Radial Force and Precision for Iliac Arteries
Cell architecture for an uniform radial force and excellent scaffolding
Exclusive stent design for negligible foreshortening to maximize implant precision
Bio Inducer Surface with its exceptional bio&haemo compatibility, seals the bulk Nitinol material (Nickel-Titanium alloy) avoiding any release of heavy metal ions.

14. Clinical Project: Easy Flype Registry
PTA CON EasyFlype NELL’OCCLUSIONE DELL’A. FEMORALE SUPERFICIALE IN PAZIENTI “REAL WORLD”
Pazienti ‘Real World’ con arteriopatia aterosclerotica sintomatica con steno-occlusione dell’arteria femorale superficiale
300 patients
12 Italian Sites*
OBJECTIVE: Valutare l’efficacia nella pervietà primaria del dispositivo Easy Flype nel trattamento endovascolare dell’arteriopatia aterosclerotica in pazienti sintomatici con steno-occlusione dell’arteria femorale
PRIMARY ENDPOINT: Valutare la pervietà primaria a 6 mesi e 12 mediante osservazione clinica , ABI Index ed Ecocolordoppler 6M
12M
* Arezzo (Bellandi) – Bologna (Sensi) - Empoli (Credi) – Firenze (Michelagnoli) - Grosseto (Natale) – Napoli (Selvetella) – Nuoro (Fadda) – Pistoia (Sabato) – Reggio Calabria (Volpe) – Reggio Emilia (Vecchiati) – Tricase (Palasciano) – Venezia (Dorrucci)

15. CID and Bio Inducer Surface: New Entry
Now AVAILABLE

16. Cre8TM BTK: distinctive features
Abluminal Reservoir Technology
Amphilimus™ Formulation: Sirolimus + organic acid
BIS: Bio Inducer Surface

17. Abluminal Reservoir Technology
CID utilizes a proprietary polymer-free drug release system constituted by reservoirs on the stent's outer surface.
ARTERIAL WALL
Drug elution is controlled and directed exclusively towards the vessel wall
BLOOD FLOW
Lack of any polymer
Lack of any drug
Co-Cr thin stent strut: 80 µm

18. ART: controlled and directed drug elution
The Cre8™release kinetic has been defined fixing the parameters inside the Fick’s law *
* Cre8 implants in rabbit model
Fick’s law
Peak drug tissue concentration during the first days
50% drug elution in approximately 18 days
65%-70% drug elution within 30 days
Complete drug elution within 90 days

19. Amphilimus™ Formulation
During Drug Release
After Drug Release (3 months)
BMS covered with
Bio Inducer Surface (BIS)
Pure carbon coating
Excellent haemo/bio compatible features
No late inflammatory stimuli inside the treated segment
(Sirolimus + organic acid)
CID AmphilimusTM Formulation
Sustained drug elution
Modulated drug bioavailability
Raised homogeneous drug distribution
Enhanced drug stability

20. Cre8TM BTK features for improved efficacy in diabetics
1) Polymer-free with controlled abluminal elution
2) Cre8 BTK employs a permeation enhancer (organic acid) in its formulation
Fatty acids are used to improve transdermal and skin delivery of many different drugs.
ARTERIAL WALL
Drug elution is precisely controlled
Cardiac fatty acid uptake is double in diabetic mice model.
DICLOFENAC
BLOOD FLOW
Lack of any polymer
Lack of any drug
NO Polymer
reduced inflammatory trigger
Drug +
Permeation enhancer
Increased drug concentration

21. Cre8TM: Results Preclinical study in pig model
7 days FU
90 days FU
BMS + BIS
Cre8 = DES + BIS
Cypher
Moretti et al, Eurointervention 2012;7:

22. Primary Endpoint: 6-month in-stent Late Lumen Loss
NEXT Study
Primary Endpoint: 6-month in-stent Late Lumen Loss
Overall Population
Diabetic subgroup
P<0.0001
0.14±0.36
0.34±0.40
0.43±0.41
- 60%
- 72%
0.12±0.29
P=0.0002
Cre8
(162 pts)
TAXUS Liberté
(161 pts)
p value
Diabetes
29.6% (48/162)
24.2% (39/161)
0.2735
ID Diabetes
6.2% (10/162)
6.8% (11/161)
0.8101
Non-ID Diabetes
23.5% (38/162)
17.4% (28/161)
0.1765
D. Carriè, “A Multicenter Randomized Trial Comparing Amphilimus- With Paclitaxel-Eluting Stents in De Novo Native Coronary Artery Lesions”; J. Am. Coll. Cardiol Apr 10; 59(15):

23. Conclusions
The exclusive Bio inducer Surface coating accelerates endothelization and struts coverage, reduces thrombogenity and seals against the release of heavy metal ions like nickel from Nitinol alloy;
All the devices are designed to optimize efficacy and safety performances thanks to their innovative features and Abluminal Reservoir Technology and all CID Italian Technology are driven by improving clinical patients’ conditions.