Californian device/pharma company Elixir Medical Corporation has received CE Mark approval for its DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System. The scaffold is designed to degrade in about one year returning the patients’ coronary vessel ultimately to its normal de novo state.
Elixir Medical is a developer of product platforms that combine state-of-the-art medical devices with advanced pharmaceuticals. Its 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.
Elixir says the unique attributes of the DESolve scaffold system include its ability to self-appose to the nominal vessel wall size in cases of 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.
Results of the international pivotal DESolve Nx trial, designed to enroll 120 patients at 15 centers in Europe, Brazil and New Zealand were submitted as part of the CE Mark application, and will be presented in Paris during the EuroPCR 2013 congress on Tuesday, May 21.
The DESolve Nx trial represents one of the largest bioresorbable scaffold clinical trials with QCA (quantitative coronary angiography) follow-up in the industry to date.
Elixir intends to initiate commercial sales of DESolve in a broad range of sizes in select international markets later this year.
“The CE Mark approval for DESolve brings to the market a differentiated product platform with important advantages,” said Martin Leon, MD, New York – Presbyterian Hospital / Columbia University Medical Center, New York, NY, and Chairman of Elixir Medical’s DESolve Scaffold Program. “Elixir’s DESolve may help to transform the interventional treatment of patients with coronary artery disease by providing optimal vessel support when needed and degrading in about a year leaving the vessel free of a permanent metallic implant.”
“The CE Mark for DESolve is a major milestone that confirms the impressive results of the device performance observed in the clinical setting,” said Stefan Verheye, M.D., Ph.D., ZNA Middleheim Hospital, Antwerp, Belgium, and co-Principal Investigator of the DESolve Nx study. “Having used the DESolve bioresorbable scaffold system in the First-In-Man study and observed its outstanding performance in the clinic during the subsequent DESolve Nx pivotal trial, I am confident that Elixir’s fully bioresorbable DESolve system is poised to lead the next frontier of interventional cardiology innovation.”
“The CE Mark approval of Elixir’s DESolve represents a major achievement in interventional cardiology as it brings together important performance characteristics that physicians are seeking for the better treatment of their patients,” said Alexandre Abizaid, M.D., Ph.D., Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil, and co-Principal Investigator of the DESolve Nx trial. “DESolve’s unique characteristics include its ability to maintain radial strength and vessel support for the critical period of vessel healing, the ability to self-appose to the nominal vessel wall, its excellent scaffold expansion range, and its ability to degrade in the body in about a year.”
“The goal of the interventional cardiologist is to treat and return the patient arteries to their de novo state. We believe the DESolve scaffold makes this goal a reality,” said Motasim Sirhan, Chief Executive Officer of Elixir Medical. “With the approval of DESolve, Elixir fulfills its commitment to having the most comprehensive product portfolio of three CE Mark approved drug-eluting systems spanning all market segments – including the DESyne BD Novolimus Eluting Coronary Stent System (with biodegradable polymer) and the DESyne Novolimus Eluting Coronary Stent System (with durable polymer) — providing clinicians with the best choice of customizing patient treatment to achieve optimal clinical outcomes.”
Source: Elixir Medical Corporation, Business Wire