The company also revealed new information about its suite of Fantom Encore products, noting that the devices will have strut profiles of 95 microns, 105 microns and 115 microns.
Reva’s Fantom II trial included 240 patients and a primary endpoint consisting of cardiac death, myocardial infarction and target lesion revascularization. The company reported a 5% rate of major adverse cardiac events after two years, pointing out that it compares favorably with the 6-11% target lesion failure rates usually seen with drug-eluting stents or bioresorbable scaffolds.
The study’s investigators reported a 0.4% rate of scaffold thrombosis, as well as sustained vessel lumen patency without evidence of chronic scaffold recoil, Reva said.
“The 2-year results from the Fantom II trial are very promising for Fantom,” said Dr. Alexandre Abizaid, who presented the results at EuroPCR. “Fantom offers advantages relative to first-generation bioresorbable scaffolds such as a thinner strut profile and x-ray visibility. The data indicate that Fantom’s advantages are translating into positive outcomes for patients.”
Reva’s Fantom devices are made using a proprietary bioresorbable polymer called Tyrocore. Early bioresorbable scaffolds have suffered due to concerns about a heightened risk of myocardial infarction and scaffold thrombosis linked to the devices. But Reva has argued that first-gen scaffolds were limited, in part, due to their thick strut profiles.