The new approval covers Reva’s Fantom 3.0 and 3.5 mm diameter devices, helping the company expand beyond its already-approved 2.5 mm diameter scaffold.
Reva’s third-generation coronary bioresorbable scaffold features a thinner strut profile than previous iterations of the device. The scaffold is made from Reva’s proprietary Tyrocore polymer.
“With this approval we have reached an important milestone in our commercial growth plan for our coronary scaffolds,” CEO Reggie Groves said in prepared remarks. “In addition to pursuing distribution partnerships and increasing our clinical evidence to support marketing activities, we have extended our technological lead in this area. We are on track to launch the Fantom Encore product line later this year.”
In May, Reva touted two-year results of its 240-patient Fantom II trial. The study included a primary endpoint consisting of cardiac death, myocardial infarction and target lesion revascularization. Reva 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 also reported a 0.4% rate of scaffold thrombosis, as well as sustained vessel lumen patency without evidence of chronic scaffold recoil.