Elixir Medical Announces Excellent Six-Month Safety and Efficacy Results for the CE-Marked Fully Bioresorbable DESolve® Novolimus Eluting Coronary Scaffold System at Late Breaking Clinical Trial Session of EuroPCR
SUNNYVALE, Calif.--(BUSINESS WIRE)--May 21, 2013--Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced excellent six-month clinical trial results today from the DESolve Nx international pivotal clinical trial for the CE Mark-approved, fully bioresorbable DESolve Novolimus Eluting Coronary Scaffold System. The positive clinical and angiographic results were presented during the EuroPCR session of “From Late Breaking Trial to Clinical Practice” in Paris today by Alexandre Abizaid, M.D., Ph.D., Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil, and co-Principal Investigator of the DESolve Nx trial. The trial represents one of the largest in the industry for bioresorbable scaffolds with angiographic, IVUS, OCT, and MSCT imaging modality follow ups.
A total of 126 patients were enrolled at 13 centers in Europe, Brazil and New Zealand in the DESolve Nx pivotal trial. 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.
At 6 months, Elixir’s DESolve demonstrated an excellent late loss of 0.21±0.34 mm as measured by QCA. IVUS imaging results demonstrated statistically significant increase in the scaffold and lumen area between post procedure and 6-month follow-up with no aneurysm formation or late acquired ISA (incomplete scaffold apposition). OCT imaging results demonstrated impressive 99% strut coverage with a thin and uniform 0.10 mm neointimal layer and no late acquired ISA. A low 3.25% MACE (Major Adverse Cardiac Events) rate was reported, and there was no definite scaffold thrombosis. Furthermore, a post-hoc comparison of clinical and imaging results of the diabetic subset of patients demonstrated similar results.
“DESolve is the first scaffold that degrades in about one year while achieving excellent clinical safety and efficacy outcomes by having low acute recoil, the required radial strength with no chronic recoil, and the optimal drug dose to suppress neointimal proliferation,” said Abizaid. “The DESolve results set a high standard for scaffold performance and clinical outcomes.” “DESolve is the first product to demonstrate scaffold and lumen area increase at six months, re-establishing the vessel’s natural ability to positively remodel,” said Stefan Verheye, MD, PhD, ZNA Middleheim Hospital, Antwerp, Belgium, and co-Principal Investigator of the DESolve Nx trial. “These impressive results have the potential to create a paradigm shift in the treatment of patients with cardiovascular disease.” “Unlike permanent metallic implants, Elixir’s DESolve scaffold is designed to un-cage the vessel and allow vascular restoration at six months,” said Motasim Sirhan, Chief Executive Officer of Elixir Medical. “DESolve eventually will return the patient artery to its de novo state and establish a new standard in clinical outcomes.” Elixir Medical is the only company with three CE Mark-approved drug-eluting systems spanning all market segments: the DESyne ® BD Novolimus Eluting Coronary Stent System (with biodegradable polymer), the DESyne ® Novolimus Eluting Coronary Stent System (with durable polymer), and the DESolve ® Novolimus Eluting Coronary Scaffold System. Earlier this month, the company announced US Food and Drug Administration’s IDE (Investigational Device Exemption) approval to commence the EXCELLA III Clinical Trial with Elixir’s durable polymer Novolimus Eluting Coronary Stent System in the United States.
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 (a) its ability to self-appose up to the nominal vessel wall size in cases of malapposition; (b) its ability to maintain radial strength and vessel support for the necessary period of vessel healing while degrading in about a year and (c) 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