ABSTRACT
This chapter shows the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System is comprised of a poly-L-lactic-acid (PLLA)-based polymer scaffold and the drug Novolimus. The overexpansion and through-strut expansion capabilities of the DESolve scaffold were employing independent bench testing methods. The DESolve scaffold system has been evaluated in two clinical trials. In the first study, a Myolimus eluting DESolve scaffold was investigated in a multicenter DESolve first-in-man (FIM) trial in which 15 patients with single de novo lesions were treated. In the second study, following refinement of the DESolve scaffold which included the use of Novolimus instead of Myolimus along with a broader spectrum of device sizes was investigated in the DESolve Nx pivotal study. Both the DESolve FIM and DESolve Nx studies demonstrated the safety and efficacy of the DESolve scaffold which appears to be comparable with the second generation ABSORB PLLA bioresorbable vascular scaffold.
