Fantom: performance gains and clinical data for a next-generation BRS Lukasz Koltowski 1st Department of Cardiology Medical University of Warsaw Exhibit 99.3
Speaker's name: Lukasz Koltowski I have the following potential conflicts of interest to report: Receipt of grants / research supports: REVA Medical Receipt of honoraria or consultation fees: Medtronic, REVA Medical Potential conflicts of interest
BRS in STEMI: Rationale so far… Younger patients Low astherosclerosis burden Patient Proximal segments Lipid-rich soft plaque Less calcifications More focal/shorter lesion Lesion Snow shoe effect Scaffold
BVS-RAI Cortese et al. Am J Card. 2015 BRS in STEMI BVS-RAI & BVS-EXAMINATION p=0.06 p=0.37 p=0.44 p=0.38 p=0.84 p=0.40 BVS-EXAMINATION Brugaletta et al. JACC Card. Interv. 2015
Tomaniak, Kochman, Koltowski et al , JACC Cardiovasc. Int 2017 (in print) Still, BRS in STEMI needs improvment
Fantom in STEMI: Rationale 1. Snow shoe effect Source: 1) PLLA scaffold IFU, 2) Data of file, REVA Lower thickness Greater surface coverage Greater thickness Smaller surface coverage PLLA scaffold Fantom scaffold 150 um 125 um Surface coverage 32% (2.5 mm) 27% (3.0 mm) 27% (3.5 mm) Surface coverage 33% (2.5 mm) 31% (3.0 mm) 27% (3.5 mm)
Fantom in STEMI: Rationale 2. Low recoil & high radial strength Force to permanently deform scaffold in IRIS compression in 37°C H2O Tested on final scaffold 4.0% 3.5% 3.0% 2.5% systems (crimped, 2.0% sterilized and deployed) at 37°C in H2O Adequate radial strength Low recoil PLLA scaffold Fantom scaffold
Fantom in STEMI: Rationale 3. Substantial expansion range 0.75 - 1.0 mm depending upon device size Able to adjust for vessel taper & dilatation Polymer enables expansion to 3.75 mm without fracture
Fantom in STEMI: Rationale 4. Radiographic Visibility Precise scaffold placement & lesion coverage Proper structural assessment after implantation Less dependent on IVUS/OCT imaging compared to other BVS Xience, DES Fantom Koltowski L (unpublished image)
5. Improved healing profile Data on file, Reva Corp. Fantom in STEMI: Rationale Fewer residual plateles @3 months
First Fantom implantation in STEMI Huczek Z (unpublished data) 2 hour CP ECG: STEMI inferior ASA Ticagrelor UFH Occluded RCA Large thrombus Case: [VIDEO]
First Fantom implantation in STEMI Huczek Z (unpublished data) Thrombectomy + pre-dilatation + Fantom (3.5 x 24 mm) Post-dilatation NC 3,5 x 8 (20 atm.) [VIDEO] [VIDEO]
First Fantom implantation in STEMI Huczek Z (unpublished data) ST resolution No chest pain Procedural success OCT evaluation [VIDEO]
First Fantom implantation in STEMI Huczek Z (unpublished data) [VIDEO]
FANTOM STEMI pilot study Single-arm, prospective STEMI (de novo, 2.5-3.5 RVD, <20 mm, no bif., no calc.) Proper implantation technique (PSP, 1:1 NC) Intravascular imaging follow-up Baseline 6 mo 18 mo 36 mo OCT NIRS/IVUS OCT NIRS/IVUS OCT NIRS/IVUS OCT NIRS/IVUS Vasomotion Vasomotion QoL QoL QoL QoL Clinical Clinical Clinical Clinical Design: Study flow: Koltowski L (unpublished design)
Thank you. "In theory, theory and practice are the same. In practice, they are not.” [Albert Einstein]
