Reva Medical (ASX:RVA) has won CE Mark clearance for its thin strut Fantom Encore bioresorbable, drug-eluting scaffold.
The sirolimus-eluting vascular scaffold, which is made from Reva’s Tyrocore polymer, features a 95-micron strut profile and x-ray visibility.
“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,” Dr. Matthias Lutz, who performed the device’s first implant in Kiel, Germany, said in prepared remarks.
“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,” he added.
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 improved vessel healing, according to the company.
“Approval of Fantom Encore is a significant milestone in bioresorbable polymer and scaffold technology,” CEO Reggie Groves added. “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.”
Reva said it expects to launch the entire Fantom Encore product line later this year, after securing CE Mark clearance for the 3.0- and 3.5-mm diameter sizes.
Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.