REVA Medical has announced that it released final six-month safety data on the complete patient population enrolled in the FANTOM II clinical trial at the Transcatheter Cardiovascular Therapeutics (TCT) conference.
Dr. Alexandre Abizaid, co-principal investigator for the trial and Director of Invasive Cardiology at Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil, presented the data during TCT’s First Report Investigations.
The FANTOM II trial is evaluating the safety and performance of the Company’s Fantom® sirolimus-eluting bioresorbable scaffold (“BRS”), a second generation BRS designed to overcome the limitations of first-generation scaffolds that are currently used worldwide.
The trial enrolled a total of 240 patients, in two Cohorts, between March 2015 and March 2016. REVA previously reported a Major Adverse Cardiac Events (“MACE”) rate of 2.56% for 117 patients enrolled in Cohort A of the trial.
The 123 patients enrolled in Cohort B have now completed their six-month clinical assessment; the combined MACE rate for the entire patient population through six months is 2.1%.
Additionally, the clinical data showed a final in-scaffold LLL for patients in Cohort A of 0.25mm (±0.40 mm) and an in-segment LLL of 0.17 mm (±0.34 mm), which compare favorably to the rates of commercially available competitive bioresorbable scaffolds and drug-eluting stents.
“The low MACE rate reported for the 240 patients treated with Fantom demonstrates a strong safety profile through this time point,” stated Dr. Abizaid. “We look forward to seeing the longer-term data as these patients continue their imaging and clinical assessments through five years.”
Also today, Jo Simonsen, research fellow from Aarhus University Hospital, Skejby in Denmark, presented six-month Optical Coherence Tomography (“OCT”) results on a sub-set of patients from the trial.
The OCT imaging results in 73 Cohort A patients treated with Fantom demonstrated continued vessel patency and promising healing results with 98% strut coverage at six months.
The First Report Investigation and OCT presentation materials delivered at the conference are being filed with the Australian Securities Exchange and with the U.S. Securities and Exchange Commission.