Reva Medical announced the commercial launch of the Fantom Encore bioresorbable scaffold and the first implant of the device in the FANTOM Post Market trial. Matthias Lutz (Universitätsklinikum Schleswig-Holstein, Kiel, Germany) performed the implant procedure. According to a press release, Fantom Encore is a third-generation coronary bioresorbable scaffold with a market-leading thin strut profile compared with other commercially available, CE marked scaffolds.
The press release states that the Fantom Encore is immediately available in all countries where the Reva Medical is currently selling its second-generation Fantom coronary scaffold, including Germany, Switzerland, Austria, Belgium, the Netherlands, Luxembourg, Italy and Turkey.
Lutz, co-principal investigator of the FANTOM Post Market trial, says: “My experience with Fantom Encore is that it is easy to use due to its thinner strut profile, X-ray visibility, and strength, device improvements and the investment in the FANTOM Post Market trial, Reva Medical is partnering with physicians to advance the field of bioresorbable scaffolds.”
According to the press release, Fantom Encore offers differentiated features compared to first-generation bioresorbable scaffolds such as Absorb, including thinner profiles, improved ease-of-use, and full X-ray visibility. These advantages are derived from Reva’s Tyrocore polymer, which is different from the polylactic acid polymer used to construct Absorb. Fantom Encore’s features, including thinner strut profiles, have been associated with improved outcomes and ease-of-use—which are critical for broader adoption of bioresorbable scaffold technology.
Reggie Groves, CEO of Reva Medical, comments: “The commercial launch of Fantom Encore solidifies Reva’s technological lead in bioresorbable scaffolds. No other company has a thin strut profile, X-ray visible bioresorbable scaffold. With a leading product and clinical data generated through the FANTOM clinical trials, we are positioned for success in the coronary bioresorbable scaffold market.”
The FANTOM Post Market trial is a single arm trial to assess the continued safety and performance of Fantom and Fantom Encore. The primary endpoint is target lesion failure at 12 months and patients will be followed through five years. The FANTOM Post Market trial is currently enrolling with a target of 1,500 patients at 50 to 100 European centres.