US-based Elixir Medical has announced positive one-year results from the DESolve Nx international pivotal clinical trial for the CE Mark-approved, 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 trial represents one of the largest multi-modality imaging studies in the industry for bioresorbable scaffolds with angiographic, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and multi slice coherence tomography (MSCT) follow ups.
Results using MSCT, 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 six 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 0.10mm neointimal layer and confirmed no late acquired ISA.
Bioresorbable scaffold technology had thus far been a challenge in the industry because it required a level of strength and support that only permanent metallic stents had been able to provide while resorbing and maintaining excellent clinical outcomes.
The 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.
Elixir Medical CEO Motasim Sirhan noted the company is fulfilling its commitment to providing the broadest and most innovative product portfolio for cardiologists to address their patients' needs.
"DESolve holds the promise to transform the interventional cardiology industry by raising the bar in clinical outcomes while leaving nothing behind," Sirhan added.
The fully bioresorbable DESolve scaffold, developed from a proprietary and proven poly-L Lactide (PLLA)-based polymer, provides optimal strength and support to the artery while delivering the novel anti-proliferative drug, Novolimus.
The unique attributes of the DESolve scaffold system include: its ability to demonstrate lumen area increase at six months demonstrating vascular restoration; its ability to self-appose up to the nominal vessel diameter resolving minor malapposition; its 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.