Golden Tube Visualization, Low MACE and Lumen Gain Sustained Long-Term
Sunnyvale, Calif. – October15, 2015 -- Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced excellent 3-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 outstanding clinical and imaging results to a packed audience of the international cardiology community gathered at the 27th annual TCT (Transcatheter Cardiovascular Technologies) Conference in San Francisco, California.
At 36 months, DESolve continued to show a low overall MACE (Major Adverse Cardiac Event) rate (8.2%) with no definite stent thrombosis, no AMI (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 QCA (Quantitative Coronary Angiography) showed no additional significant late lumen loss. Neointimal suppression was also sustained at 18 and 36 months, with no significant late TLR (Target Lesion Revascularization).
“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,” said Stefan Verheye, MD, PhD, Antwerp Cardiovascular Center, ZNA Middelheim, Antwerp, Belgium, and Co-Principal Investigator of the DESolve Nx Trial. “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.”
“Elixir is proud to be the only company in the world that has demonstrated the ‘golden tube’ visualization between 18 and 36 months and sustained results through 36,” said Motasim Sirhan, CEO of Elixir Medical. “DESolve remains the only bioresorbable scaffold to date in the world that maintains the lumen gain achieved at 6 months even at the 3-year mark.”
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) its ability to self-appose up to the nominal vessel diameter resolving minor malapposition; (c) its ability to maintain radial strength and vessel support for the necessary period of vessel healing while degrading in about a year; and (d) its ability to have a wide margin of expansion.
About Elixir Medical
Elixir Medical is the only company with three CE Mark-approved drug-eluting systems spanning all market segments: the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold system, the DESyne® BD Novolimus Eluting Coronary Stent System (with biodegradable polymer), and the DESyne® Novolimus Eluting Coronary Stent System (with durable polymer). The company has also received US Food and Drug Administration’s IDE (Investigational Device Exemption) approval to commence the EXCELLA III Clinical Trial in the United States with Elixir’s durable polymer Novolimus Eluting Coronary Stent System.
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.