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V. Dorrucci (Venezia). Azienda ULSS 12 Veneziana S.C. di Chirurgia Vascolare ed Endovascolare Dipartimento CardioToracoVascolare Direttore: Dr Vittorio.

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Presentation on theme: "V. Dorrucci (Venezia). Azienda ULSS 12 Veneziana S.C. di Chirurgia Vascolare ed Endovascolare Dipartimento CardioToracoVascolare Direttore: Dr Vittorio."— Presentation transcript:

1 V. Dorrucci (Venezia)

2 Azienda ULSS 12 Veneziana S.C. di Chirurgia Vascolare ed Endovascolare Dipartimento CardioToracoVascolare Direttore: Dr Vittorio Dorrucci DISPOSITIVI INNOVATIVI SVILUPPATI PER OTTIMIZZARE L'EFFICACIA E LA SICUREZZA: UNA REALTÀ ITALIANA GUIDATA DALLA TECNOLOGIA. 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 sp 3 bonds The nature of pure carbon coatings depends on their closeness to the molecular structure of diamonds (sp 3 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 CID has developed Bio-Inducer Surface: Getting a faster endothelialization

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 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. Pyrolytic Carbon

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 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 The worst setting for trombotic events Sorin St. Jude Carbomedics Medtronic …others....

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 Bio Inducer Surface with its exceptional bio&haemo compatibility, seals the bulk Nitinol material (Nickel-Titanium alloy) avoiding any release of heavy metal ions. 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

14 PTA CON EasyFlype NELLOCCLUSIONE DELLA. FEMORALE SUPERFICIALE IN PAZIENTI REAL WORLD Clinical Project: Easy Flype Registry Pazienti Real World con arteriopatia aterosclerotica sintomatica con steno-occlusione dellarteria femorale superficiale 300 patients 12 Italian Sites* OBJECTIVE: Valutare lefficacia nella pervietà primaria del dispositivo Easy Flype nel trattamento endovascolare dellarteriopatia aterosclerotica in pazienti sintomatici con steno-occlusione dellarteria femorale PRIMARY ENDPOINT: Valutare la pervietà primaria a 6 mesi e 12 mediante osservazione clinica, ABI Index ed Ecocolordoppler 6M12M * 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 Now AVAILABLE CID and Bio Inducer Surface: New Entry

16 Cre8 TM BTK: distinctive features Abluminal Reservoir Technology Amphilimus Formulation: Sirolimus + organic acid BIS: Bio Inducer Surface

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

18 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 * * Cre8 implants in rabbit model The Cre8release kinetic has been defined fixing the parameters inside the Ficks law ART: controlled and directed drug elution Ficks law

19 CID Amphilimus TM Formulation Sustained drug elution Modulated drug bioavailability Raised homogeneous drug distribution Enhanced drug stability Amphilimus Formulation (Sirolimus + organic acid) During Drug ReleaseAfter 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

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

21 Cre8 TM : Results Preclinical study in pig model 7 days FU90 days FU Moretti et al, Eurointervention 2012;7: BMS + BIS Cre8 = DES + BIS Cypher

22 P< ± ± ± ±0.41 P= Diabetic subgroup Overall Population - 72% - 60% NEXT Study Primary Endpoint: 6-month in-stent Late Lumen Loss Cre8 (162 pts) TAXUS Liberté (161 pts) p value Diabetes 29.6% (48/162)24.2% (39/161) ID Diabetes 6.2% (10/162)6.8% (11/161) Non-ID Diabetes 23.5% (38/162)17.4% (28/161) 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.


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