Biotronik has announced the CE approval and launch of the Freesolve resorbable magnesium scaffold (RMS).
This third generation RMS has been engineered to provide optimised vessel support, yet achieves magnesium resorption within 12 months, the company says in a press release.
Recent BIOMAG-I trial data highlights a 99.3% magnesium strut degradation 12 months after implantation, consistent performance, regardless of lesion characteristics, and restoration of vasomotion, the press release adds.
“Having closely observed the evolution of resorbable magnesium scaffolds, the Freesolve RMS achieves a 99.3% resorption rate at 12 months and provides better scaffolding than its predecessors,” said Michael Haude (Rheinland Klinikum, Neuss, Germany). “The enhanced properties of the Freesolve RMS can establish a true alternative to DES, benefitting from the advantages of a resorbable device while maintaining a reliable and predictable outcome with the long-term safety profile that has already been shown in many RMS trials with previous versions.”