REVA Announces CE Mark and First Implant of the Fantom Encore Bioresorbable Scaffold
SAN DIEGO, Feb. 26, 2018 (GLOBE NEWSWIRE) -- REVA Medical, Inc. (ASX:RVA) (“REVA” or the “Company”), a leader in bioresorbable polymer technologies for vascular applications, announces CE Mark of the 2.5 millimeter diameter size and the first implant of the Fantom®Encore bioresorbable scaffold (“BRS”). The 2.5 millimeter diameter size of Fantom Encore has a market-leading 95 micron strut profile. The first implant procedure was conducted by Dr. Matthias Lutz at the Universitätsklinikum Schleswig-Holstein in Kiel, Germany.
“Fantom Encore has the thinnest strut profile of any available bioresorbable scaffold in the 2.5 millimeter diameter size. A thinner profile can improve ease-of-use during the implant procedure and vessel healing following the procedure,” said Dr. Lutz. “My experience with Fantom Encore was a successful implantation procedure, and it was easy to see with x-ray. Bioresorbable scaffolds have the potential to improve long-term outcomes compared with metal drug-eluting stents and are an important treatment option for my patients.”
Fantom Encore offers a thinner strut profile compared to the original Fantom without compromising strength or visibility under x-ray. Like the original Fantom, Fantom Encore is made from Tyrocore™, REVA’s proprietary tyrosine-derived polymer designed specifically for vascular scaffold applications. Additionally, Fantom Encore leverages the same antiproliferative drug (Sirolimus), scaffold design, and balloon delivery system as Fantom. REVA achieved a thinner profile without compromising strength or x-ray visibility by developing improved polymer processing and manufacturing techniques.
Bioresorbable scaffolds were developed as an alternative to metal drug-eluting stents for the treatment of coronary artery disease. The first generation of bioresorbable scaffolds were limited by their thick profiles, approximately 150 microns, which are higher than average drug-eluting stent profiles. Fantom and Fantom Encore are second and third generation scaffolds, respectively, offering thinner profiles compared to first generation scaffolds as well as x-ray visibility. These features have the potential for improved ease-of-use and vessel healing, which are critical for broader commercial adoption of the technology.
The Company will begin initial commercial introduction of the 2.5 millimeter size of Fantom Encore at select centers while it pursues CE Mark of the 3.0 and 3.5 millimeter diameter sizes. REVA expects to launch the entire Fantom Encore product line later this year.
“Approval of Fantom Encore is a significant milestone in bioresorbable polymer and scaffold technology. REVA developed a novel polymer, Tyrocore, and then used it to create a bioresorbable scaffold with the most advanced features available: x-ray visibility and a 95 micron profile,” said Reggie Groves, CEO, REVA Medical. “To date, we have received very positive feedback from our Fantom customers. We expect that Fantom Encore will deliver the next level of performance as we expand commercialization of our bioresorbable scaffolds.”
Fantom and Fantom Encore are sirolimus-eluting bioresorbable scaffolds developed as an alternative to metallic stents for the treatment of coronary artery disease. Scaffolds provide restoration of blood flow, support the artery through the healing process, and then disappear (or “resorb”) from the body over a period of time. This resorption is intended to allow the return of natural movement and function of the artery. Fantom and Fantom Encore are the only bioresorbable scaffolds made from Tyrocore, REVA’s proprietary tyrosine-derived polymer designed specifically for vascular scaffold applications. Tyrocore is inherently radiopaque, making Fantom and Fantom Encore the first and only bioresorbable scaffolds that are visible under fluoroscopy. Fantom and Fantom Encore are designed with thin struts while maintaining strength and with distinct ease-of-use features such as expansion with one continuous inflation.
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 lead products are the Fantom and Fantom Encore bioresorbable vascular scaffolds for the treatment of coronary artery disease. REVA is located in San Diego, California, USA and employs over 50 people in the U.S. and Europe.
Fantom, Fantom Encore, and Tyrocore are trademarks of REVA Medical, Inc.
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, including the risks and uncertainties that are described in the "Risk Factors" section of our Annual Report on Form 10-K filed with the US Securities and Exchange Commission (the “SEC”) on February 28, 2017, and as updated in our periodic reports thereafter. 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.
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