Fantom®
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Catalog excerpts

Fantom® - 1

Fantont ordering information Tyrocore Bioresorbable Scaffold Excellent Clinical Performance through 2 Years 3.0 mm Fantont scaffold specifications Delivery system specifications Description Bioresorbable coronary scaffold Catheter type Rapid exchange Scaffold material Guide catheter compatibility Coating material Working catheter length Shaft outer diameters Drug dose Strut thickness Nominal pressure Maximum expansion diameter Rated burst pressure Side branch access Size (mm) Side cell expansion (mm) 2.5 2.0 Balloon material Crossing profile avoid excessive heat and keep dry n = 240 *TLF = cardiac death + target vessel Ml + target lesion revascularization. The FANTOM II primary endpoint was Major Adverse Cardiac Events (MACE) = cardiac death + all Ml + target lesion revascularization. The 24-month MACE rate was 5.0%. Sustained vessel patency and strut coverage1 References: 1. Data on file at REVA Medical. MACE rates presented: Abizaid, A. New 24-month data from the FANTOM II clinical trial. EuroPCR 2018. 2. Ellis S, Kereiakes, D. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent: ABSORB III. ACC 2017. 3. Haude M, et al. Short and midterm safety, clinical performance and multimodality imaging results of the drug-eluting absorbable metal scaffold: Combined data of the BIOSOLVE-II and BIOSOLVE-III trials. EuroPCR 2017. FANTOM II 24-month OCT analysis:matched OCT images at baseline, 6 months, and 24 months, n=25 4. Stone G, et al. Randomized Comparison of Everolimus- and Paclitaxel-Eluting Stents 2-Year Follow-Up From the SPIRIT IV Trial. JACC 2011;58(1):19-25. 5. Mauri L. 2-year clinical outcomes from the pivotal RESOLUTE US study. Presented ACC 2012. 6. Holm, NR. REVA FANTOM II performance and healing patterns by OCT two-year serial follow up. EuroPCR 2018. 7. Values include coating. Absorb, DESolve, Magmaris source: Foin, N. Biomechanical Assessment of Bioresorbable Devices. CRT 2017. 8. Ormiston, J. New BRS Platforms. Presented at EBC Rotterdam 2016. 9. Product Instructions for Use. 10.Radial strength measured at 15% compression. Tests performed by and data on file at REVA Medical. REVA Medical European Authorized Representative HealthLink Europe BV, De Tweeling 20-22,5215 MC ’s-Hertogenbosch, The Netherlands. TEL: +3173 303 2559 EMAIL; revamedical@healthlinkeurope.com These products are intended for use by or under the direction of a physician. Prior to use, it is important to read the package Insert thoroughly for instructions for use, warnings, and potential complications associated with the use of this device. CE Mark only. Fantom is not available for sale in the U.S. or countries that do not accept CE Mark. All illustrations are artist's representations only and should not be considered as engineering drawings or photographs. Photo(s) taken by and on file at REVA Medical. Fantom and Tyrocore are trademarks of REVA Medical, Inc. Absorb is a trademark of Abbott. DESolve NX is a trademark of Elixir Medical. Magmaris is a trademark of Biotronik. Baseline 6 Months 24 Months Baseline 6 Months 24 Months TTVA www.revamedical.com

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Fantom® - 2

ENTER A NEW ERA FOR BRS DELIVERABILITY 1st and only radiopaque BRS made with Tyrocore Fantont is visible under x- ray Fantont simplifies BRS deployment Tyrocore is REVA's proprietary iodinated desaminotyrosine polycarbonate based polymer designed specifically for vascular scaffolds. Single-step balloon inflation9: Direct inflation to intended diameter. Increases speed for scaffold delivery. Reduces arterial occlusion time. Higher expansion tolerance9: Limit of expansion over nominal, 3.0 mm scaffolds. 0.8 0.6 0.5 0.5 0.4 0.2 mm Absorb DESolve NX Magmaris Fantont Accommodates post...

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