Outstanding 4-Year Data for DESolve Nx Trial Confirms Long-Term Performance of CE Mark-approved DESolve® Bioresorbable Scaffold System
Sunnyvale, CA – November 1, 2016 — Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, today announced excellent 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. The unique attributes of the DESolve Cx scaffold system include its ability to (a) demonstrate lumen area increase at six months demonstrating vascular restoration; (b) degrade within one year designed to eliminate late scaffold-related events; (c) maintain radial strength and vessel support for the necessary period of vessel healing while degrading; and (d) have a wide margin of expansion.
Excellent, Four-year Clinical and Imaging Results for the CE-Mark Approved Fully Bioresorbable DESolve® Novolimus Eluting Coronary Scaffold System Reaffirm Long-Term, Sustained Performance
Elixir Medical has also announced excellent 4-year clinical and imaging results from the DESolve Nx international pivotal clinical trial for the CE Mark-approved, fully bioresorbable DESolve® Novolimus Eluting Coronary Scaffold System. Professor Alexandre Abizaid, M.D., Ph.D., of The Instituto Dante Pazzanese de Cardiologia, Brazil, and Co-Principal Investigator of the DESolve Nx Trial, presented the clinical and imaging results to a packed audience of the international cardiology community gathered at the 28th annual TCT (Transcatheter Cardiovascular Therapeutics) Conference in Washington, DC.
The DESolve® scaffold is completely resorbed in the vessel wall within 18 and 36 months, and at the four year end point, well after full resorption, the system continues to show a low overall MACE rate (9.0%) with no definite stent thrombosis.
“The DESolve scaffold has been completely resorbed for some time now, and I’m delighted to see sustained and excellent long-term results and patent vessels in patients” said Dr. Abizaid. “The golden tube formation within 18 to 36 months and the continued low incidence of MACE through 4 years clearly reinforces the unparalleled advantage of DESolve Nx over other modes of treatment, and even expands its potential for evaluation in new clinical indications.”
“DESolve remains the only bioresorbable scaffold in the world that achieves lumen gain at 6 months while maintaining excellent safety and patency rate up to 4 years,” said Motasim Sirhan, Chief Executive Officer of Elixir Medical.
DESolve Nx pivotal trial enrolled 126 patients at 13 centers in Europe, Brazil and New Zealand. At 6 months, Elixir’s DESolve demonstrated excellent mean late lumen loss of 0.20±0.32 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 fully bioresorbable DESolve 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. The unique attributes of the DESolve scaffold system include (a) its ability to demonstrate lumen area increase at six months demonstrating vascular restoration; (b) degrade within one year designed to eliminate late scaffold-related events; (c) its ability to maintain radial strength and vessel support for the necessary period of vessel healing while degrading; and (d) its ability to have a wide margin of expansion.
About Elixir Medical
Elixir Medical Corporation, a privately held company headquartered in Sunnyvale, California, develops products that combine state-of-the-art medical devices with advanced pharmaceuticals to provide innovative treatment solutions to patients worldwide. The company’s next-generation drug-eluting stent systems and bioresorbable coronary scaffold are designed to optimize localized drug delivery to provide safe and effective treatments for cardiovascular patients. For more information, visit www.elixirmedical.com.