State and Future of Satellites and Airborne Platforms Mark Schoeberl GSFC.
Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark...
Transcript of Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark...
![Page 1: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/1.jpg)
Altres plataformes: situacio actual
Salvatore BrugalettaHospital Clinic i Provincial, Barcelona
![Page 2: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/2.jpg)
CE-mark platforms
No CE-mark platforms
Altres plataformes: situacio actual
![Page 3: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/3.jpg)
CE-mark platforms
No CE-mark platforms
Altres plataformes: situacio actual
![Page 4: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/4.jpg)
CE-mark approved bioresorbablescaffolds
![Page 5: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/5.jpg)
![Page 6: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/6.jpg)
Mechanical properties
Reduced elasticity and strengthas compared to metallic stent
![Page 7: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/7.jpg)
DESolve innovation
![Page 8: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/8.jpg)
DESolve Nx TrialProspective one-arm study with 126 patients2-year clinical follow-up (122 patients)6-month QCA (113 patients) IVUS (40 patients)OCT follow-up (38 patients)
Abizaid JACC Intv 2016;9:565-74
![Page 9: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/9.jpg)
DESolve Nx Trial: 6-month late loss
0.20±0.32 mm
![Page 10: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/10.jpg)
DESolve Nx Trial: IVUS and OCT
Increase in scaffold area during 6-month
![Page 11: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/11.jpg)
DESolve Nx Trial: 2-year ClinicalOutcomes
![Page 12: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/12.jpg)
Fantom (Reva Medical Inc.)Optical properties comparison
Radiopaque platformEluting sirolimus
![Page 13: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/13.jpg)
FANTOM II study (240 patients)
![Page 14: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/14.jpg)
History of Magmaris scaffold
0.25±0.22
3.4
0.0
![Page 15: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/15.jpg)
BIOSOLVE-II first-in-man trial (n=123 pts)
One-year TLF 3.4%. No events beyond 6M. No definite/probable ST
![Page 16: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/16.jpg)
Magmaris vs. Absorb vs. OrsiroImmunofluorescence
Waksman R et al. Circulation Cardiovascular Interventions
![Page 17: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/17.jpg)
Magmaris vs. Absorb vs. OrsiroImmunofluorescence
![Page 18: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/18.jpg)
Magmaris vs. 316L-equivalentImmunofluorescence
![Page 19: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/19.jpg)
148 patients with STEMI (< 6 hrs)1:1 randomization
MAGMARIS CohortN = 74
ORSIRO CohortN = 74
Thrombectomy +/-predilatation
Scaffolding (M-BRS) Stenting (DES)
Sizing max
+/- postdilatation / thrombectomy based on angiographic guidance
Primary endpoint: vasodilatatory response ≥ 3% after nitroglycerininjection at 1-year FU
NTG injection, OCT evaluation (subgroup 40 pacients)
Thrombectomy +/-predilatation
NTG injection, OCT evaluation (subgroup 40 pacients)
MAGSTEMI trial
![Page 20: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/20.jpg)
CE-mark platforms
No CE-mark platforms
Altres plataformes: situacio actual
![Page 21: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/21.jpg)
Firesorb BRS (Microport)
![Page 22: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/22.jpg)
![Page 23: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/23.jpg)
Clinical outcomes
![Page 24: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/24.jpg)
OCT Data
![Page 25: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/25.jpg)
MeRes 100 (Meril)
![Page 26: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/26.jpg)
MeRes-1 Study (108 pts, 116 lesions)
![Page 27: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/27.jpg)
MeRes-1 Study (108 pts, 116 lesions)
6-month OCT data 6-month Late loss
![Page 28: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/28.jpg)
APTITUDE Sirolimus-eluting BRS(Amaranth Medical)
![Page 29: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/29.jpg)
RENASCENT II study (60 Patients)
9-month late loss 0.19±0.26 mm
Low MACE rate (3.4%, due to 2 non-Q-wave
MI)
Scaffold stability as assessed by OCT lumen
area
High level of strut coverage (97%)
Colombo A EuroPCR 2017
![Page 30: Hospital Clinic i Provincial, Barcelona€¦ · Hospital Clinic i Provincial, Barcelona CE-mark platforms No CE-mark platforms Altres plataformes: situacio ́ actual CE-mark platforms](https://reader031.fdocuments.net/reader031/viewer/2022011823/5edc41b2ad6a402d6666d96f/html5/thumbnails/30.jpg)
Take-Home Messages
Development of other bioresorbableplatforms is slow but active, showinginteresting and favourable data
Large and randomized trials are neededto evaluate its safety and to understandwhich patient may benefit most from thistechnology