Back in May of this year Elixir Medical gained CE Mark approval for its absorbable drug eluting stent. Now TCT 2013 has come round the company has seen one year results from its pivotal study presented. Data suggests the thing works rather well.
It’s not difficult to imagine the challenge faced by developers of bioresorbable stents. The scaffold technology required a level of strength and support that only permanent metallic stents had been able to provide, while resorbing and maintaining excellent clinical outcomes. Elixir claims its DESolve Novolimus Eluting Bioresorbable Coronary Scaffold overcomes these challenges and achieves vascular restoration within six months. DESolve is the first scaffold to achieve this objective at such early time point.
So to TCT2013, where Elixir Medical saw study co-principal investigator Stefan Verheye, M.D., Ph.D., ZNA Middleheim Hospital, Antwerp, Belgium present one-year results from the DESolve Nx study. This was the international pivotal clinical trial established to support the now CE Marked fully bioresorbable DESolve® Novolimus Eluting Coronary Scaffold System.
At one year, the DESolve Nx trial demonstrated a low MACE (Major Adverse Cardiac Events) rate of 5.69% with no definite scaffold thrombosis. The results were presented by .
Results using MSCT (Multi Slice Coherence Tomography), a noninvasive imaging modality to visualize coronary arteries and the manifestations of coronary artery disease, demonstrated a mean lumen area of 5.5 ± 2.2 mm2 at one year, maintaining the results that were observed at 6 months using other imaging modalities
At 6 months, Elixir’s DESolve demonstrated excellent mean late lumen loss of 0.21±0.34 mm as measured by QCA. IVUS imaging results demonstrated a statistically significant increase of 9% in the lumen area between post procedure and 6-month follow-up with no late acquired ISA (incomplete scaffold apposition). OCT imaging results demonstrated an impressive 99% strut coverage with a thin and uniform 0.10 mm neointimal layer and confirmed no late acquired ISA.
“The 12-month results of the DESolve scaffold demonstrated sustained clinical outcomes at one year, further validating the scaffold as an excellent treatment option for coronary artery disease,” said Dr. Verheye. DESolve Nx pivotal trial enrolled 126 patients at 13 centers in Europe, Brazil and New Zealand. In addition to Quantitative Coronary Angiography (QCA) follow-up on all patients, a subset of 46 patients underwent Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) imaging at baseline and 6-month follow-up.
“DESolve is the first product to degrade in about one year, demonstrate lumen area increase at six months, and maintain the lumen at 18 months as demonstrated during the live case follow up” said Professor Alexandre Abizaid, M.D., Ph.D. who performed a live 18 month follow-up from San Paolo during the TCT event. “These impressive results can create a paradigm shift in the treatment of patients with cardiovascular disease.”
“Elixir is fulfilling its commitment to providing the broadest and most innovative product portfolio for cardiologists to address their patients’ needs,” said Motasim Sirhan, Chief Executive Officer, Elixir Medical. “DESolve holds the promise to transform the interventional cardiology industry by raising the bar in clinical outcomes while leaving nothing behind.”
Source: Elixir Corporation