The DESolve novolimus bioresorbable Scaffold: from bench to bedside

Abstract

The DESolve (Elixir Medical Corporation, Sunnyvale, California, USA) is a poly-L lactide-based polymer scaffold coated with the antiproliferative and anti-inflammatory drug novolimus. The scaffold biodegrades within one year with a complete resorption in two years and in vitro bench test have shown the ability to supply the necessary radial strength to support the vessel for the critical 3- to 4-month period after implant. The DESolve showed the unique self-correction property, which may reduce the incidence of minor malapposition after deployment. Overexpansion with DESolve is safe since a high capability resistance to fracture has been demonstrated with this scaffold. The aim of this review is to provide a comprehensive overview of the available preclinical and clinical data regarding the DESolve.

Keywords: DESolve; Scaffold; bioresorbable scaffolds (BRS).

Figure 1

DESolve Nx scaffold. Sinusoidal rings are connected to consecutive ring by three connectors. Two platinum iridium markers are localized at each end. DESolve Nx has CE mark for sizes overwritten, DESolve XL for large vessel 4.0 mm is recently evaluated in a First-In-Man registry.

Figure 2

The DESolve family. (A) DESolve Nx (first generation): strut thickness 150 µm; (B) DESolve Cx (second generation): 20% reduction of strut thickness (120 μm) to minimize areas of flow disturbance, without compromising radial strength or recoil; (C) DESolve NTx (third generation, clinical trials ongoing): 120 μm contoured struts to improve acute performance (optimization of lesion expansion, increase of scaffold embedding into the vessel) and improvement of scaffold visibility. TRASFORM balloon technology is characterized by a central segment expansion 0.25 mm larger than the end segments (3 mm) at nominal pressure.