Transcript 4. The CID technological approach to the open

Elena Matteucci
Global Product Manager - CID Spa
I, Elena Matteucci, have the following financial
interest/arrangement or affiliation:
CID employee
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Scenario setting specific
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Patients related issues
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Post-procedural implications
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Dedicated platforms and delivery systems setting specific
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Unique fundamental features every-setting required
Dedicated platforms and delivery
systems setting specific
Renal Stent
Iliac Stent
BTK Stent
Femoral Stent
Unique fundamental features everysetting required
PRECISE POSITIONING
RADIAL FORCE / FLEXIBILITY
FAST ENDOTHELIAZATION & OPTIMIZED CLINICAL OUTCOMES
Unique fundamental features everysetting required
PRECISE POSITIONING
RADIAL FORCE / FLEXIBILITY
FAST ENDOTHELIAZATION & OPTIMIZED CLINICAL OUTCOMES
Unique fundamental features everysetting required
PRECISE POSITIONING
STENT MARKERS
guarantee perfect placement
exceptional visibility
ZERO FORESHORTENING UPON EXPANSION
preserving the original stent length
Unique fundamental features everysetting required
UNIQUE CELLS DESIGN
PRECISE POSITIONING
RADIAL FORCE / FLEXIBILITY
FAST ENDOTHELIAZATION…
BX Stents
SX Stents
Unique fundamental features everysetting required
PRECISE POSITIONING
RADIAL FORCE / FLEXIBILITY
FAST ENDOTHELIAZATION & OPTIMIZED CLINICAL OUTCOMES
BIO INDUCER SURFACE
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
Carbomedics
Medtronic (ATS)
St. Jude
...others...
The Bio Inducer Surface (BIS)
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Graphite
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Bio/haemo-compatibility
The Bio-Inducer Surface is made of pure carbon atoms
Diamond
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
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
The Bio Inducer Surface
in coronary arteries
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Continuous endothelial layer @ 5d
3.9% of struts uncovered @ 4/7d
in preclinical study
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.
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
Drug Eluting Stent - BX and SX – today available
STANDARD POLYMERIC DES
STANDARD NO POLYMERIC DES
Polymer drug elution towards vessel wall
No guarantee controlled drug elution
towards vessel wall
Polymer + drug towards lumen
CID DES efficacy free from limits
Abluminal Reservoir
Technology - ART
Amphilimus™ Formulation:
Sirolimus + organic acid
BIS: Bio Inducer Surface
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
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
The amount of drug released overtime is
proportional to the area of contact and to the
drug concentration gradient
Kinetic examples
CID DES efficacy free from limits - IV
Amphilimus™ Formulation : Sirolimus + Organic Acid
Specific properties/contributions
Sirolimus
Immunosuppressant
Anti-proliferative action
Anti-microbial
Inhibitor of inflammatory cell
activities
• High potency
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Amphiphilic carrier
• Sustained drug elution timing
• Modulated drug bioavailability
• Raised homogeneous drug
distribution
• Enhanced drug stability
Conclusions
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The technological contents of today available implantable devices are not
meeting all physicians needs in endovascular settings
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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
Assoc. Prof. V. Chervenkoff
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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
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61 y.o. male
Peripheral occlusive arterial disease: rest pain
in the left lower extremity
ABI sin – 0
Comorbidities: IHD, AH, T2DM, Dislipidemia
CTO of the left common iliac
artery
Highly calcified plaque
Initial angiogram
Intraluminal recanalisation – verifying the true
lumen proximal to the lesion
Implanting a balloon expandable BMS
Completion angiogram
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Low profile
High radial force
Precise implantation
Suitable size
Fracture resistancy
Isthmus, 9x59 mm, 75 cm, 6F
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Lower class Fontaine PAOD from III to IIa
ABI sin from 0 to 0.55
18 months follow-up