CE mark for 2.5mm Fantom Encore bioresorbable scaffold

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Fantom

According to a press release, Reva Medical has received the CE mark for its 2.5mm Fantom Encore bioresorbable scaffold and that the scaffold has been implanted for the first time. Matthias Lutz (Universitätsklinikum Schleswig-Holstein, Kiel, Germany) implanted the scaffold, which has—the press release notes—a market-leading 95-micron strut profile.

Fantom Encore has been designed to offer a thinner strut profile compared with the original Fantom without compromising strength or visibility under x-ray. Like the original Fantom, Fantom Encore is made from Tyrocore—Reva Medical’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. The press release states Reva Medical achieved a thinner profile without compromising strength or X-ray visibility by developing improved polymer processing and manufacturing techniques.

Lutz comments: “Fantom Encore has the thinnest strut profile of any available bioresorbable scaffold in the 2.5mm diameter size. A thinner profile can improve ease-of-use during the implant procedure and vessel healing following the procedure. 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.”

Reva Medical will begin initial commercial introduction of the 2.5mm size of Fantom Encore at select centres while it pursues CE mark of the 3mm and 3.5mm diameter sizes. It expects to launch the entire Fantom Encore product line later this year. Reggie Groves, CEO of Reva Medical, notes: “

“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.

“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.”

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