REVA MEDICAL ANNOUNCES FINAL 5 YEAR RESULTS FOR IT’S FANTOM II CORONARY SCAFFOLD STUDY
Dr. Matthias Lutz of the University Medical Center Schleswig-Holstein (Kiel, Germany) presented the fully adjudicated 5-year results from the landmark FANTOM II Trial at the 2022 EuroPCR conference in Paris, France. These results demonstrate the ongoing safety and efficacy of the Fantom Sirolimus-Eluting Bioresorbable scaffold through full degradation and resorption from the body. The Fantom device continues to deliver better clinical outcomes than what has been seen in many permanent metal drug eluting stent trials. The low 5-year Target Lesion Failure (TLF) rate of 5.8% demonstrates a long-term trend of favorable patient outcomes in the trial. This is important because the two essential requirements of cardiac stents- to support the vessel during the healing process and to deliver drugs to prevent restenosis-are temporary needs. Therefore, the long-term complications of permanent stents are avoided.
In addition to the final 5-year results from the FANTOM II Trail, Dr. Lutz also presented the 36-month results from a follow-on study that specifically evaluated the use of multiple Fantom scaffolds in treating longer more complex lesions. This smaller sub-study has continued to confirm the initial and long-term safety and performance of the Fantom coronary bioresorbable scaffold in a more complex real world patient population.
Presentation material delivered at the conference is available at REVA’s website: www.revamedical.com.
About REVA Medical
REVA Medical is a medical device company focused on the development and commercialization of bioresorbable polymer technologies for vascular applications. The Company’s products include MOTIV bioresorbable scaffolds for the treatment of peripheral artery disease, Fantom and Fantom Encore bioresorbable vascular scaffolds for the treatment of coronary artery disease, and TyroSphere embolic beads. REVA is based in San Diego, California. More information can be found at REVA’s website: www.revamedical.com.
Fantom, Fantom Encore, and MOTIV have CE Mark only. Fantom, Fantom Encore, and MOTIV are available in select countries in Europe and the Middle East. Fantom, Fantom Encore, MOTIV, and TyroSphere are not available in the U.S. or other countries that do not accept CE Mark. Fantom, Fantom Encore, MOTIV, TyroSphere, and Tyrocore are trademarks of REVA Medical, LLC.
Forward-Looking Statements
This announcement contains or may contain forward-looking statements that are based on management's beliefs, assumptions, and expectations and on information currently available to management. All statements that are not statements of historical fact, including those statements that address future operating plans or performance and events or developments that may occur in the future, are forward-looking statements, such as those statements regarding the projections and timing surrounding commercial operations and sales, clinical trials, pipeline product development, and future financings. No undue reliance should be placed on forward-looking statements. Although management believes forward-looking statements are reasonable as and when made, forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to vary materially from those expressed in forward-looking statements. Any forward-looking statements in this announcement speak only as of the date when made. REVA does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Douglas Henson
REVA Medical, LLC
+1 858-966-3024
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