The implant procedure was performed by Dr Matthias Lutz at the Universitätsklinikum Schleswig-Holstein in Kiel, Germany.
Fantom Encore is a third-generation coronary BRS with a market-leading thin strut profile compared to other commercially available, CE Mark BRS.
Why use a bioresorbable scaffold? After treating a blocked #artery, the scaffold supports the vessel during the critical healing period but will begin to degrade after a year to increase options for future medical treatments. https://t.co/0UMipgm5bX #interventionalcardiology pic.twitter.com/YBgKCQqMxU— REVA Medical (@revamedicalinc) October 29, 2018
The scaffold will be immediately available in all countries where REVA is currently selling its second-generation Fantom coronary BRS, including Germany, Switzerland, Austria, Belgium, the Netherlands, Luxembourg, Italy and Turkey.
REVA CEO Reggie Groves said: “The commercial launch of Fantom Encore solidifies REVA’s technological lead in bioresorbable scaffolds
“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.”
What makes Fantom different from other scaffolds is the biocompatible polymer Tyrocore. Within about 4 years, the scaffold will degrade and safely be excreted through the kidneys and lungs. #scienceiscool #interventionalcardiology pic.twitter.com/Ygagi1EFFu— REVA Medical (@revamedicalinc) October 31, 2018
REVA’s post-market trial is a single arm trial to assess the continued safety and performance of Fantom and Fantom Encore.
The primary endpoint is target lesion failure (TLF) at 12 months and patients will be followed through five years.
The post-market trial is currently enrolling with a target of 1,500 patients at 50 to 100 European centres.