Six-month data from the 240-patient trial supported CE Mark approval for the device in Europe last month. Data through 12 months demonstrated a 4.2% rate of major adverse cardiac events. The company added that there were no reported cases of late or very late scaffold thrombosis.
A subset of patients underwent angiographic imaging to determine late lumen loss at 6 and 9 months. At 6 months, the data showed a final in-segment late loss of 0.17mm. That number jumped to 0.29mm at 9 months, falling within the desired range of 0.20 mm to 0.40 mm.
Reva also reported 9-month optical coherence tomography results, showing continued vessel patency and sustained healing with greater than 99% strut coverage.
“Data from the Fantom clinical trial through 12 months continues to demonstrate a positive safety profile for Fantom,” co-principal investigator Dr. Alexandre Abizaid said in prepared remarks. “These results, sustained through an extended timeframe, provide additional confidence about the future outlook for this next-generation bioresorbable scaffold.”
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