Reva Medical's 2.5-mm Fantom Encore Bioresorbable Scaffold Receives CE Mark Approval

February 26, 2018—Reva Medical, Inc. announced European CE Mark approval of the 2.5-mm-diameter size of its Fantom Encore bioresorbable scaffold. The company will begin commercial introduction of the 2.5-mm Fantom Encore at select centers while it pursues CE Mark approval of the 3- and 3.5-mm-diameter sizes. The entire Fantom Encore product line is expected to be launched later this year.

According to the company, the Fantom Encore has a 95-µm strut profile, which is thinner compared with the original Fantom without compromising strength or visibility under x-ray. Like the original device, Fantom Encore is made from Tyrocore, Reva's tyrosine-derived polymer designed specifically for vascular scaffold applications. It also features the same antiproliferative drug (sirolimus), scaffold design, and balloon delivery system as Fantom. 

The first implantation of the device after approval was performed by Matthias Lutz, MD, at the Universitätsklinikum Schleswig-Holstein in Kiel, Germany.

In the company's press release, Dr. Lutz commented, "Fantom Encore has the thinnest strut profile of any available bioresorbable scaffold in the 2.5-mm-diameter size. A thinner profile can improve ease-of-use during the implant procedure and vessel healing following the procedure."

Dr. Lutz added, "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."