1. Elena Matteucci Global Product Manager - CID Spa
The CID technological approach to the open questions in peripheral vascular intervention
Elena Matteucci
Global Product Manager - CID Spa

2. Disclosure Statement of Financial Interest
I, Elena Matteucci, have the following financial interest/arrangement or affiliation: CID employee

3. Peripheral Procedures Outcomes
Scenario setting specific
Patients related issues
Post-procedural implications

4. What do physicians need from implantable devices?

5. ..improved clinical outcomes..
..in Femoral Procedures
..improved clinical outcomes..

6. ..improved technical features such as:
..in Iliac Procedures
..improved technical features such as:
- Precise deployment
- Radial force
- Flexibility
- Deliverability

7. ..in Renal Procedures
..avoid geographic miss

8. ..a gold standard solution to improve clinical outcomes
..in BTK Procedures
..a gold standard solution to improve clinical outcomes

9. The CID technological approach

10. The CID technological approach
Dedicated platforms and delivery systems setting specific
Unique fundamental features every-setting required

11. Dedicated platforms and delivery systems setting specific
Renal Stent
Iliac Stent
Femoral Stent
BTK Stent

12. Unique fundamental features every-setting required
PRECISE POSITIONING
RADIAL FORCE / FLEXIBILITY
FAST ENDOTHELIAZATION & OPTIMIZED CLINICAL OUTCOMES

13. Unique fundamental features every-setting required
PRECISE POSITIONING
RADIAL FORCE / FLEXIBILITY
FAST ENDOTHELIAZATION & OPTIMIZED CLINICAL OUTCOMES

14. Unique fundamental features every-setting required
PRECISE POSITIONING
STENT MARKERS
guarantee perfect placement
exceptional visibility
ZERO FORESHORTENING UPON EXPANSION
preserving the original stent length

15. Unique fundamental features every-setting required
UNIQUE CELLS DESIGN
PRECISE POSITIONING
BX Stents
SX Stents
RADIAL FORCE / FLEXIBILITY
FAST ENDOTHELIAZATION…

16. Unique fundamental features every-setting required
PRECISE POSITIONING
RADIAL FORCE / FLEXIBILITY
FAST ENDOTHELIAZATION & OPTIMIZED CLINICAL OUTCOMES
BIO INDUCER SURFACE

17. Heart valve: the worst setting for thrombotic events
Pyrolitic Carbon (PyC) is the only material used to realize mechanical heart valve leaflets since more than 35 years thanks to its un-matched thrombo-resistant properties
Sorin
St. Jude
Carbomedics
Medtronic (ATS)
...others...

18. The Bio Inducer Surface (BIS)
The Bio-Inducer Surface is made of pure carbon atoms
Bio/haemo-compatibility
Diamond
Graphite % %
This 2nd generation pure carbon coating (≤0.3 µm) brings the cristalline structure closer to the diamond structure with a further improvement of its bio/haemo compatibility

19. BIS - Foreseen clinical impact
The BIS coating is the only surface in contact with vessel wall and blood stream
BIS
BMS
Time
Day 0
Thrombo-resistant surface
Pro-thrombotic surface
Day 3
Partially endothelialized + thrombo-resistant surface
Pro-thrombotic surface
Day 7
Endothelialized surface
Partially endothelialized + pro-thrombotic surface
Slide pictures are of a purely illustrative nature and are not intended to depict reality

20. The Bio Inducer Surface in coronary arteries
Continuous endothelial 5d in preclinical study
3.9% of struts 4/7d in ACS patients
# Stent implants in pig coronary arteries. University of Turin. Anal Bional Chem 2012 Oct 9.
J Cardiovasc Med (hagerstown) 2012 Apr 19.

21. The Bio Inducer Surface in peripheral settings
Benefits in endothelization
Reduced restenosis in high restenosis setting due to flow turbolences – e.g. ostial lesions
Seals the bulk Nitinol material (Nickel-Titanium alloy) avoiding any release of heavy metal ions
Reduced risk of thrombosis especially high in long stents implantation and in distal lesion with low ABI index, because there is no metal in contact with the vessel wall and the blood flow

22. The CID future developments

23. Drug Eluting Stent - BX and SX – today available
Drug Eluting Stents
Drug Eluting Stent - BX and SX – today available
STANDARD POLYMERIC DES
Polymer drug elution towards vessel wall
Polymer + drug towards lumen
STANDARD NO POLYMERIC DES
No guarantee controlled drug elution
towards vessel wall

24. CID DES efficacy free from limits
Abluminal Reservoir Technology - ART
Amphilimus™ Formulation: Sirolimus + organic acid
BIS: Bio Inducer Surface

25. CID DES efficacy free from limits -II
Abluminal Reservoir Technology - ART
CID utilizes a proprietary polymer-free drug release system (ART) 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
No interaction with endothelization process

26. CID DES efficacy free from limits - III
Controlled and directed drug elution - ART
The reservoir’s design directly impacts on drug amount and release kinetic
FICK’S LAW
Kinetic examples
The amount of drug released overtime is proportional to the area of contact and to the drug concentration gradient

27. CID DES efficacy free from limits - IV
Amphilimus™ Formulation : Sirolimus + Organic Acid
Specific properties/contributions
Sirolimus
Amphiphilic carrier
Immunosuppressant
Anti-proliferative action
Anti-microbial
Inhibitor of inflammatory cell activities
High potency
Sustained drug elution timing
Modulated drug bioavailability
Raised homogeneous drug distribution
Enhanced drug stability

28. Conclusions
The technological contents of today available implantable devices are not meeting all physicians needs in endovascular settings
CID has focused its development efforts into 3 different areas:
- unique design attributes optimizing visibility, positioning and mechanical performances
- Bio-inducer-surface to fast endothelization and improve clinical outcomes
- Polymer –free DES technology with controlled elution to enhance device performance in complex endovascular clinical conditions

29. Interventions in highly calcified iliac arteries
Assoc. Prof. V. Chervenkoff

30. Dealing with highly calcified lesions of the iliac arteries could be a very challenging task.
Extremely hard plaques
Higher risk of vessel rupture
Difficult navigation of the devices

31. Clinical case
61 y.o. male
Peripheral occlusive arterial disease: rest pain in the left lower extremity
ABI sin – 0
Comorbidities: IHD, AH, T2DM, Dislipidemia

32. Preoperative CT-Angiography
CTO of the left common iliac artery
Highly calcified plaque

33. Stages of intervention
Initial angiogram

34. Stages of intervention
Intraluminal recanalisation – verifying the true lumen proximal to the lesion

35. Stages of intervention
Implanting a balloon expandable BMS

36. Stages of intervention
Completion angiogram

37. What made our choice? Low profile High radial force
Precise implantation
Suitable size
Fracture resistancy

38. What did we used
Isthmus, 9x59 mm, 75 cm, 6F

39. Outcomes Lower class Fontaine PAOD from III to IIa
ABI sin from 0 to 0.55
18 months follow-up

40. Thank you for attention!