Biovascular scaffold - Description & Data

Presentation on Biovascular scaffold

1. Bioabsorbable Vascular Scaffold

2. overview History & evolution of BVS Advantages Types of BVS Physiology of BVS Clinical trails of BVS Future perspectives of BVS

3. POTENTIAL ADVANTAGE OF BVS

4. ADVANTAGES of BVS 1. A reduction in adverse events such as late ST . Because drug elution and scaffolding are temporary 2.The removal, through bioabsorption , of the rigid caging of the stented vessel. This can facilitate the return of vessel vasomotion , adaptive shear stress, late luminal enlargement , and late expansive remodeling. Furthermore, this might reduce the problems of jailing of the ostium of side branches as seen with permanent metallic stent struts

5. ADVANTAGES of BVS 3.A reduction in bleeding complications. No requirement for long-term dual antiplatelet therapy. 4.An improvement in future treatment options. The treatment of complex multivessel disease frequently results in the use of multiple long DES The use of a BRS would mean that there would potentially be no restriction on any future percutaneous or surgical revascularization should they be needed

6. 5.Allowing noninvasive imaging (CT/MR angio .) Metallic stents can cause a blooming effect with these imaging modalities, making interpretation more difficult. The (PLLA) scaffold should not restrict the use of CT or MRI because it is nonmetallic; once bioabsorption has been completed with a BRS, it should also not restrict the use of CT or MRI Noninvasive imaging follow-up could therefore become an alternative to invasive imaging followup BVS , WHERE ARE WE

7. Vasomotion As Absorb resorbs , the treated vessel segment is able to react to changes in blood flow and physiological stimuli that may occur with exercise or certain drugs. By no longer supporting or caging the vessel, there is the potential for allowing the vessel to respond naturally to physiological stimuli, which could provide unique benefits.

8. Importance of Respecting Natural Vessel Curvature Long-term flow disturbances and chronic irritation can contribute to adverse events Gyöngyösi, M. et al . J Am Coll Cardiol. 2000;35:1580-1589. Wentzel, J. et al . J Biomech. 2000;33:1287-1295. 91° 88° Stiff Metal Stents BVS (Cohort B case) Pre BVS Post BVS Serruys, P. , TCT 2009 BVS appears to maintain natural vessel curvature at implantation; long-term, scaffold is fully resorbed

9. What is Required of a Fully Bioresorbable Scaffold to Fulfill the Desire for ‘Vascular Restoration Therapy’? Revascularization Restoration Resorption to 3 months 3 to ~6-9 months + ~9 months + Performance should mimic that of a standard DES Transition from scaffolding to discontinuous structure Implant is discontinuous and inert Good deliverability Minimum of acute recoil High acute radial strength Controlled delivery of drug to abluminal tissue Excellent conformability Gradually lose radial strength Struts must be incorporated into the vessel wall (strut coverage) Become structurally discontinuous Allow the vessel to respond naturally to physiological stimuli Resorb in a benign fashion

10. Fourth revolution All these problems promise to be solved with the advent of fully biodegradable scaffolds. Offers the possibility of Transient scaffolding of the vessel to prevent acute vessel closure and recoil & Transiently eluting an antiproliferative drug to counteract the constrictive remodeling and excessive neointimal hyperplasia

11. Regulatory Status Only 2 have the Conformité Européenne (CE) mark for use in coronary artery disease: Absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular) DESolve scaffold (Elixir Medical Corporation). The Igaki-Tamai stent (Kyoto Medical Planning Co., Ltd.) also has the CE mark, but only for peripheral use. No devices have U.S. Food and Drug Administration approval.

12. The degradation of Mg produces an electronegative charge that results in the stent being hypothrombogenic . Although the stent was completely absorbed within 2 months, radial support was lost much earlier so that, perhaps within days, there was an insufficient radial strength to counter the early negative remodeling forces after PCI. In addition, it did not release an antiproliferative drug to counter the intimal hyperplastic response to stenting . Consequently, there was a high restenosis rate at 4 months of almost 50% and target vessel revascularization at 1 year was 45% PROGRESS AMS trial: Lancet. 2007;369:1869 –1875 . BIOABSORBABLE MAGNESIUM STENT

13. The BVS stent design is characterized by a crossing profile of 1.4 mm with circumferential hoops of PLLA. The struts are 150 um thick Both ends of the stent have 2 adjacent radiopaque platinum markers. The radial strength = BMS. Everolimus -Eluting PLLA Stent: BVS Scaffold

14. Absorb Design Elements

15. Clinically Tested BRS

16. ABSORB Cohort A A prospective, open-labeled, non-randomized N = 30; 6 sites (Europe, New Zealand) Clinical follow-up schedule: 30 days, 6 months, 12 months, annually to 5 years Imaging schedule: QCA, IVUS, OCT, IVUS VH Baseline 6 18 24 Months Months Months MSCT (optional)

17. BVS Device Optimization Cohort A Cohort B Photos taken by and on file at Abbott Vascular. Changes with BVS 1.1 More uniform strut distribution More even support of arterial wall Lower late scaffold area loss Maintain radial strength for at least 3 months Storage at room temperature Improved device retention Unchanged: Material, coating and backbone Strut thickness Drug release profile Total degradation Time More uniform strut distribution More even support of arterial wall Lower late scaffold area loss Maintain radial strength for at least 3 months Storage at room temperature Improved device retention Unchanged: Material, coating and backbone Strut thickness Drug release profile Total degradation Time

18. Techniques in BVS

19. Limitations Larger in human trials still awaited Experience in complex lesions limited Thicker struts , Need for lesion preparation Limited sizes and expansibility Costly

20. conclusion This technology is currently still in its infancy. However, the return of normal vascular function after bioabsorption has opened a new horizon aimed at promoting “vascular restoration therapy.”

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