Three-Year Results Presented for the Elixir Medical's Desolve Novolimus-Eluting Bioresorbable Coronary Scaffold System

October 15, 2015—Elixir Medical Corporation announced 3-year clinical and imaging results from the DESolve Nx international pivotal clinical trial for the company’s CE Mark approved, fully bioresorbable Desolve novolimus-eluting coronary scaffold system. 

Prof. Alexandre Abizaid, MD, who is coprincipal investigator of the DESolve Nx trial, presented the clinical and imaging results at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 11–15 in San Francisco, California. Prof. Abizaid is from The Instituto Dante Pazzanese de Cardiologia in Vila Mariana, São Paulo, Brazil.

The company reported that at 36 months, the Desolve device continued to show a low overall major adverse cardiac event rate of 8.2% with no definite stent thrombosis, no acute myocardial infarction after 6 months, and no visible struts at 36 months. 

In terms of efficacy, the early lumen gain seen at 6 months was sustained through 3 years and quantitative coronary angiography showed no additional significant late lumen loss. Neointimal suppression was also sustained at 18 and 36 months, with no significant late target lesion revascularization.

DESolve NX trial coprincipal investigator Stefan Verheye, MD, commented in the company’s announcement, “I am delighted to see the sustained and excellent long-term vascular response and patent vessels in patients with the Desolve scaffold after it has been completely resorbed. The golden tube continuation from 18 through 36 months, with plaque regression and the restoration of the vessels to their normal physiologic condition, clearly reinforces the advantage of Desolve over other modes of treatment, and expands its potential for evaluation in new clinical indications.” Dr. Verheye is from Antwerp Cardiovascular Center, ZNA Middelheim in Antwerp, Belgium.

The DESolve Nx pivotal trial enrolled 126 patients at 13 centers in Europe, Brazil, and New Zealand. At 6 months, the Elixir Desolve demonstrated excellent mean late lumen loss of 0.2 ± 0.32 mm as measured by quantitative coronary angiography. Intravenous ultrasound imaging results demonstrated a statistically significant increase of 9% in the lumen area between postprocedure and 6-month follow-up with no late acquired incomplete scaffold apposition. Optical coherence tomography imaging results demonstrated an impressive 99% strut coverage with a thin and uniform 0.1-mm neointimal layer and confirmed no late acquired incomplete scaffold apposition.

According to the company, the fully bioresorbable Desolve scaffold system, developed from a poly-L lactide-based polymer, provides optimal strength and support to the artery while delivering the antiproliferative drug novolimus. The Desolve scaffold system offers the ability to increase lumen area at 6 months, demonstrating vascular restoration; the ability to self-appose up to the nominal vessel diameter resolving minor malapposition; the ability to maintain radial strength and vessel support for the necessary period of vessel healing while degrading in about a year; and its ability to have a wide margin of expansion.