Elixir Medical has announced six-month clinical data for the first 25-patient subset of the DESolve Cx Clinical Study at the 28th annual Transcatheter Cardiovascular Therapeutics (TCT) Conference in Washington, DC.
The DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold has a strut thickness of 120µm and degrades within one year, returning the patients’ coronary vessel to its normal de novo state. The DESolve Cx scaffold is more deliverable and designed to address the needs of a broader patient population.
At 6 months in the 25 patients, Elixir’s DESolve Cx demonstrated excellent late lumen loss of 0.18 ± 0.29 mm, no cases of scaffold thrombosis, and no (0%) clinically-driven Major Adverse Cardiac Events. Imaging results by IVUS (intravascular ultrasound) demonstrated low neointimal volume obstruction of 5%.
IVUS also showed an increase in scaffold and lumen volume between baseline and six months, also confirming early uncaging of the vessel.
Excellent acute scaffold strut apposition and embedding was observed with intravascular Optimal Coherence Tomography (OCT) imaging. The patients were enrolled in Europe and Brazil, and will continue to be followed-up through two years. The six-month results of the entire study population will be presented after follow-up completion.
The DESolve Cx clinical trial is a 50-patient, single-arm, multi-center, evaluation of the Elixir’s thin-strut DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System. The primary imaging endpoint of the study is in-stent late lumen loss assessed by quantitative coronary angiography (QCA) at six months.
The primary clinical endpoint is MACE (Major Adverse Cardiac Events), a composite of cardiac death, target vessel MI (myocardial infarction), and clinically-indicated target lesion restenosis at six months.
Secondary endpoints include MACE at 30 days, and 12 and 24 months; in-segment late lumen loss, binary restenosis, and percent diameter stenosis by QCA; in-scaffold percent volume obstruction and malapposition with IVUS (intravascular ultrasound); and in-scaffold percent obstruction and strut coverage with OCT (Optical Coherence Tomography).
Professors Alexandre Abizaid, M.D., Ph.D., of The Instituto Dante Pazzanese de Cardiologia, Brazil, and Stefan Verheye, M.D., Ph.D., ZNA Middleheim Hospital, Antwerp, Belgium, are the co-Principal Investigators of the DESolve Cx international study.
“The trial results position DESolve Cx as a strong next-generation bioresorbable scaffold system providing physicians with a promising product to improve clinical outcomes in a broad patient population,” said Dr. Abizaid.
“I’m confident that Elixir’s DESolve Cx Coronary Scaffold System has the potential to become a work-horse product that will be competitive with the best-in-class drug eluting stent systems in the clinic, and have the added advantage of being completely resorbed into the body and return vessels to a de novo state.”
“I was pleased with the acute outcomes of the procedure with DESolve Cx, and now I’m excited that the results for these initial patients continue to look excellent at 6 months,” said Dr. Verheye.
“The 6-month results for the DESolve Cx patients reinforce Elixir’s commitment of providing cardiologists with the most deliverable and user-friendly coronary scaffolds in order to realize greater adoption in everyday clinical practice,” said Motasim Sirhan, Chief Executive Officer of Elixir Medical.
“Elixir is proud to present one of the broadest and most innovative portfolios of coronary scaffolds that will help physicians realize their goal of treating and returning the patient’s coronary arteries to their de novo state.”
The fully bioresorbable DESolve™ Cx scaffold system, 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.