The TiTAN OPTIMAX Coronary Stent System is indicated for improving coronary luminal diameters in adult patients with symptomatic ischemic heart disease including patients with acute myocardial infarction (STEMI/NSTEMI, unstable angina) and patients with concomitant diabetes mellitus due to de novo coronary artery lesions.
Tino mechanism of action
TINO is a Bioactive chemical compound with unique properties whose molecular structure is made of Titanium, Nitrogen and Oxygen.
- Reduction of the inflammatory phenomenon
- Improved biocompatibility
- Reduced platelet aggregation and fibrinous growth
- Acceleration of the reendothelialization phenomenon
- Reduction of the thrombotic process
- Presence of surface NO
Tino bio-active mechanisms of action
INFLAMMATION REDUCTION
1)Steinemann ; Injury 1996 ; Vol.27 Supl.3 : SC16-22
2) Williams; Journal of Med.Engineering and Technologies; 1997 Jul; 1(4) : 195-198
PLATELET AGREGGATION & FIBRIN GROWTH REDUCTION
3) Zhang et col. Journal of Biomaterial Medical Research 1998; 42:, 128-133
4) Gotman. Journal of Endourology 1997; Vol.11 n°6 : 383-389
5) Tsyganov et col. Nuclear Instruments and methods in physics research 2007; – B257: 122-127
THROMBOGENIC PROCESS REDUCTION
6) Zhang et col. ; Surface and Coatings Technology 84 (1996) 476-479
RE-ENDOTHELIALIZATION PROMOTION
7) Yeh et col., Journal of Biomedical Material research, 2006; RES 76 A: 835-841
In vivo (animal) evidence
Titanium-Nitride-Oxide proven antiproliferative effect:
TINO Coated Stent
Circulation. 2001;104:928-933
Circulation. 2001;104:1188-1193
Bare Metal Stent
Properties of TiNO:
- Reduction of inflammation
- Reduction of platelet aggregation
- Reduction of fibrinous growth
- Reduction of the thrombotic process
- Acceleration of re-endothelialization
- Inhibition of SMC proliferation
- 44-47% reduction in neointimal proliferation vs bare stent
TiNOcoated stent provides similar neointimal proliferation reduction compared to Sirolimus eluting stents in the porcine model
Post implantation
14 days post implantation
Excellent very early neointimal coverage of bioactive stents by optical coherence tomography
Scandinavian Cardiovascular Journal, 2015;49:280-285
Stent coating with TiNO provides :
- Effective Restenosis & late Loss reduction
- Reduced platelet & fibrin deposition
- Minimized inflammation
- Minimized thrombus formation
- Fastest Re-Endothelialization and healing
- Barrier againts toxic ions release
- No Polymer & no aggressive drug
- Sustained efficacy over time
- Reduced DAPT treatment period
Prix Galien
Titan Bioactive stent has demonstrated proven performance meaning non inferiority in efficacy and superiority in safety in over 3000 patients in Coronary TiTAN stent clinical program with randomized clinical studies versus all generations of drug eluting stents in the indication of ACS (STEMI/NSTEMI) or heart attack. The 3rd generation of bioactive stent, Titan Optimax, has been awarded Prix Galien in the treatment of acute myocardial infarction.
First in man evidence
BAS @ 6 months
Significant late Loss
reduction versus Bare Metal
Stent at 6 months
BAS @ 5 years
Efficacy up to 5 years versus Bare Metal Stent
The TiNO bioactive stent technology was born jointly in France and Switzerland (Bern) among the students of Professor Gruentzig (Prof. Windecker, Professor Meier, Professor Hess)…
This technology is protected by a worldwide patent also covering the USA.
Clinical Evidence in ACS
3 RANDOMIZED UNIVERSITARY CONTROLLED TRIALS :
B.A.S (TiTAN) versus 3 GENERATIONS D.E.S in ACS
TiTAN, BIOLOGICALLY ACTIVE, stent provides a rate of MACE (Major Adverse Cardiac Event) at 1 year of the same magnitude or non-inferior compared with that of PHARMACOLOGICALLY active stents but associated with a better safety profile (AMI, Death and Thrombosis), a trend that increases over time to achieve at 5 years differences that have become significant in terms of SAFETY.
CLINICAL RESULTS in ACS
SIMILAR EFFICACY & SUPERIOR SAFETY
HOW TO EXPLAIN SUPERIORITY OF BAS OVER DES IN SAFETY ?
OCT EVIDENCE
- Low or moderate neointimal hyperplasia
- Complete endothelialization @14 days 18 & 36 months
- No visible thrombus
- No negative Late Loss
- Good vascular healing
- Short DAPT needed
- Absence or very limited neointimal hyperplasia
- Incomplete endothelialization @18 & 36 months
- Presence of thrombus @18 & 36 months
- (EES: 18% – PES: 22.2%)
- Vascular healing impeded
- Prolonged DAPT Required
Superior biomechanics
Helicoidal patented design
- Open cells design to preserve good side branch access and minimize the reduction of the collateral blood flow
- Uniform and homogeneous artery support with an optimized radial force
- Very smooth stent struts surface improving significantly the stent glide and navigability
Cobalt-Chromium inner stent platform
- Higher material density
- Reduced strut thickness
- Increased radial strength
- Improved radio-opacity
Remarkable flexibility
- Outstanding deliverability even in tortuous anatomies
- Superior lesion access an crossing
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