Reva Medical (ASX:RVA) said this week that it launched its Fantom Encore bioresorbable, drug-eluting scaffold and that the first person was treated in a post-market trial of the device.
The Fantom Encore product is a third-gen coronary bioresorbable scaffold featuring a thin strut profile and Reva’s Tyrocore polymer.
Reva noted that the device will be made immediately available in Germany, Switzerland, Austria, Belgium, the Netherlands, Luxembourg, Italy and Turkey.
The Fantom post-market trial is slated to enroll 1,500 patients and is designed to assess the continued safety and efficacy of the Fantom and Fantom Encore products. The trial’s primary endpoint is target lesion failure after 12 months. Researchers plan to follow study participants through five years.
“My experience with Fantom Encore is that it is easy to use due to its thinner strut profile, x-ray visibility, and strength,” Dr. Matthias Lutz, co-principal investigator of the Fantom post-market trial, said in prepared remarks. “With these device improvements and the investment in the Fantom Post Market Trial, Reva is partnering with physicians to advance the field of bioresorbable scaffolds.”
“The commercial launch of Fantom Encore solidifies Reva’s technological lead in bioresorbable scaffolds,” CEO Reggie Groves added. “No other company has a thin strut profile, x-ray visible BRS. With a leading product and clinical data generated through the Fantom clinical trials, we are positioned for success in the coronary BRS market.”
