Reva Medical (ASX:RVA) announced today that the company’s Fantom Encore bioresorbable vascular scaffold was used for the first time in Switzerland.
The sirolimus-eluting device, which is made from Reva’s proprietary Tyrocore polymer, features a 95-micron strut profile and x-ray visibility.
“Reva’s Tyrocore polymer makes Fantom Encore the most advanced bioresorbable scaffold with x-ray visibility and the thinnest strut profile in the 2.5 mm diameter size,” Dr. Gregor Leibundgut, who conducted the procedure, said in prepared remarks. “During the procedure, I experienced the flexibility and ease-of-use provided by a thinner strut profile as well as excellent scaffolding. A thinner strut profile, without compromising strength, as well as the excellent visibility of the scaffold are some of the most important improvements over first generation bioresorbable scaffolds.”
The company launched its commercial operations in Switzerland last year and has since won CE Mark approval in the European Union for its Fantom Encore device.
Bioresorbable scaffolds, designed to improve upon metal drug-eluting stents, have suffered in reputation thanks to concerns about an increased risk of myocardial infarction and scaffold thrombosis linked with the devices.
But Reva has argued that first-gen bioresorbable scaffolds were limited due to their thick strut profiles. Thinner profiles, like the ones sported by Fantom and Fantom Encore, help promote long-term clinical success, according to the company.
“Many of the physicians we work with believe that bioresorbable scaffolds are the future of coronary artery disease therapy. With its thin strut profile, x-ray visibility, and ease-of-use, Fantom Encore is delivering that future today,” CEO Reggie Groves added. “The first implant of Fantom Encore in Switzerland is an important step in expanding use of our technology and broader commercial adoption.”
Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.