REVA Medical, Inc. a leader in bioresorbable polymer technologies for vascular applications, today announced it has received CE Mark approval for its full Fantom® Encore product line. This covers Fantom Encore in the 3.0 and 3.5 mm diameters, expanding the approved product line beyond the 2.5 mm diameter scaffold, which has a market-leading strut profile of 95 microns.
Fantom Encore is REVA’s third-generation coronary bioresorbable scaffold. Commercialization of Fantom, a second-generation product line that previously received CE Mark approval, began in the second quarter of 2017 in Germany and has expanded to additional countries, including Switzerland, Austria, and Turkey. REVA is actively engaged in continuing its sales expansion in Europe, the Middle East and South America with distribution partners as previously announced.
“With this approval we have reached an important milestone in our commercial growth plan for our coronary scaffolds,” said Reggie Groves, REVA’s CEO. “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.”
Fantom Encore offers a thinner strut profile compared to Fantom without compromising strength or visibility under x-ray. Thinner strut profiles have been associated with improved outcomes and ease-of-use, which are critical for broader adoption of bioresorbable scaffold technology.
Like Fantom, Fantom Encore is made from Tyrocore™, REVA’s proprietary bioresorbable polymer. Fantom and Fantom Encore are second- and third-generation scaffolds, respectively, offering differentiated features compared to first-generation scaffolds such as Absorb, including thinner profiles, improved ease-of-use, and full x-ray visibility. These advantages are derived from Tyrocore, which is different from the polylactic acid polymer used to construct Absorb.
REVA recently reported positive two-year results with Fantom from the FANTOM II trial. These results included a low 5.0% rate of major adverse cardiac events (“MACE”) in 240 patients. MACE is a stringent definition of safety and efficacy combining all events related to cardiac death, myocardial infarction, and target lesion revascularization. The endpoint of target lesion failure (“TLF”) is similar to MACE but only includes myocardial infarction events that are related to the treated vessel. Following this definition, the two-year TLF rate from 240 patients in the FANTOM II trial was 4.6%. This compares favorably to two-year TLF rates for Absorb of 11.0% and Xience of 7.9% in the 2,008-patient ABSORB III trial.
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