FANTOM II Results Presented for Reva Medical's Fantom Bioresorbable Vascular Scaffold

October 31, 2016—The FANTOM II study was presented during the First Report Investigations presentations on bioresorbable stent technologies at TCT 2016, the 28th annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC.

As summarized in the TCT announcement, the FANTOM II study examined the safety and performance of native coronary artery stenting using the Fantom radiopaque desaminotyrosine polycarbonate-based sirolimus-eluting bioresorbable vascular scaffold (Reva Medical, Inc.). The primary endpoint was the incidence of major adverse cardiac events (MACE) and late lumen loss (LLL) at 6 months.

The prospective, multicenter trial enrolled a total of 240 patients across 28 clinical centers in eight countries. Patients were sequentially enrolled into two separate cohorts in which the only difference between them was a 6-month (cohort A) versus a 9-month angiographic assessment (cohort B). The cohort A group included a total of 117 patients and the cohort B group included 123 patients. At 6 months, the incidence of MACE in both cohorts was 2.1% while the mean LLL in cohort A was 0.25 ± 0.4 mm.

Alexandre Abizaid, MD, who presented the data, commented in the TCT, “Results of the FANTOM II trial demonstrate sustained performance and safety through 6 months of this novel bioresorbable scaffold. This preliminary clinical data indicates good acute performance, as well as enhanced device deliverability, minimal residual stenosis and acute recoil.”

In the press release of the First Report presentations, the TCT conference codirector Ajay Kirtane, MD, stated, “Bioresorbable stents have the potential to be greatly impactful in the treatment of coronary artery disease, and it is exciting to see these first report investigations of several new and novel stents advancing the technology forward. These results give us the first insights into their safety and efficacy, but larger randomized trials are necessary in order to establish their role in clinical practice.”