REVA Announces CE Mark and First Implant of the Fantom Encore Bioresorbable Scaffold
2.5 millimeter Diameter Size with Market-Leading 95 micron Strut Profile Secures Early Approval.
SAN DIEGO, REVA Medical, Inc., 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.”