SUNNYVALE, Calif.--(BUSINESS WIRE)--Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced excellent 3-year imaging results from the DESolve Nx international pivotal clinical trial for the CE Mark-approved, fully bioresorbable DESolve® Novolimus Eluting Coronary Scaffold System.
Dr. Stefan Verheye, M.D., Ph.D., ZNA Middleheim Hospital, Antwerp, Belgium, and Co-Principal Investigator of the DESolve Nx Trial, presented imaging results of multiple cases from a subset of 14 patients scheduled to be followed up with angiography and OCT (Optical Coherence Tomography) at three years as part of the study.
OCT imaging showed complete bioresorption of the scaffold with only the markers visible to indicate the location of the bioresorbable scaffold. The vessels showed homogeneous light reflectivity on OCT indicating refurbished endoluminal lining and formation of the 'golden tube' within a clinically relevant timeframe.
“I am very pleased to see excellent long-term vascular response and patent vessels in patients with the DESolve scaffold after it is completely resorbed,” said Dr. Verheye. “The golden tube formation within 3 years, inducing plaque regression and the restoration of the vessels to their normal physiologic condition, clearly reinforces the potential 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 within three years,” said Motasim Sirhan, President and CEO of Elixir Medical. “While the full core lab analysis is currently underway, and the final results will be presented at a future medical congress, DESolve remains the only bioresorbable scaffold to date that maintains the late lumen gain achieved at 6 months with patent vessels and minimal narrowing at the site of treatment.”
DESolve Nx pivotal trial enrolled 126 patients at 13 centers in Europe, Brazil and New Zealand. 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 excellent mean late lumen loss of 0.21±0.34 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.
Successful Live Case Implantation of DESolve® 100
Elixir also announced that on Tues., May 19, Professor Alexandre Abizaid, M.D., Ph.D., of the Instituto Dante Pazzanese de Cardiologia, Brazil, conducted a successful live case implantation of its breakthrough and fully bioresorbable CE Mark-approved DESolve® 100 Novolimus Eluting Coronary Scaffold System in a patient enrolled in DESolve 100 Study.
“The patient presented a case of complex, long, diffused disease over 55 mm in vessel length, and it was treated with two DESolve 100 scaffolds. Elixir’s DESolve 100 had excellent deliverability, trackability and conformability, which enabled me to treat the diseased artery with confidence,” said Dr. Abizaid, who performed the live case demonstration of the DESolve 100 in his cardiac catherization lab in Sao Paulo, Brazil, that was streamed live to a packed audience in Theatre Havane during the Elixir Medical Symposium at EuroPCR 2015. “I’m pleased to report that the acute outcome of the procedure was successful, and the patient is doing well.”
To support the international commercialization and reimbursement of DESolve 100, the world’s thinnest fully bioresorbable scaffold system, Elixir is conducting a post-approval clinical study with sites in Brazil and Europe. In addition to QCA follow-up on all patients, a subset of patients will undergo IVUS and OCT imaging at baseline and 6-month follow-up. All patients will be followed up at 1 year with annual clinical follow-ups through 5 years.
Elixir Medical is the only company in the world with CE Mark approval for DESolve 100, the world’s first fully bioresorbable scaffold with a dramatically thinner strut profile of 100µm (one hundred microns), which is designed to degrade within one year, returning the patients’ coronary vessel ultimately to its normal de novo state while providing market-leading deliverability and conformability. DESolve 100 is designed to make scaffolds more user-friendly, enabling cardiologists to address the needs of a broader patient population.
“The successful live case demonstration of Elixir’s DESolve 100 at EuroPCR reinforces our commitment of providing cardiologists with the world’s first fully bioresorbable scaffold that matches the thin strut profile, excellent deliverability, and enhanced conformability of market-leading coronary drug eluting stents to ensure its greater adoption in everyday clinical practice,” said Motasim Sirhan. “Elixir is proud to present the world’s broadest portfolio of coronary scaffolds that will help physicians realize their goal of treating and returning the patient’s coronary arteries to their de novo state within one year.”
The fully bioresorbable DESolve scaffold systems, 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.