Sunnyvale, Calif. – October 13, 2015 — Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced that on Mon., October 12, Professor Alexandre Abizaid, M.D., Ph.D., of The Instituto Dante Pazzanese de Cardiologia, Brazil, conducted a successful implantation of its breakthrough and fully bioresorbable DESolve® Cx Novolimus Eluting Coronary Scaffold System that was streamed live to a packed audience of international cardiologists at the 27th annual TCT (Transcatheter Cardiovascular Technologies) Conference in San Francisco, California.
A 68 year old, non-STEMI (ST segment elevation myocardial infarction)-1 patient presented a case of mid-RCA (right coronary artery) complex lesion with thrombus, and it was treated with a 3.0 x 18 mm DESolve Cx scaffold at 16 atm. The DESolve Cx scaffold was post-dilated to 3.4 mm. The scaffold was well-apposed with some minor malapposition in the proximal and distal sections. Within 9 minutes, Dr. Abizaid reported that the malapposition had been resolved as evidenced by the final OCT (Optical Coherence Tomography) demonstrating DESolve’s self-correction feature.
“Elixir’s DESolve Cx had excellent deliverability, trackability and conformability, which enabled me to treat the diseased artery with confidence. Most importantly, its unique self-correction feature for malapposed struts was the highlight of the case,” said Dr. Abizaid, who performed the live case demonstration of the DESolve Cx in his cardiac catherization lab in Sao Paulo, Brazil. “I’m extremely pleased to report that the acute outcome of the procedure was successful, and the patient is doing well. Elixir’s DESolve Cx has the potential for helping physicians improve acute patient outcomes.”
The thin struts of DESolve Cx (120µm) have been designed to maintain DESolve Nx’s unique self-correction and overexpansion capabilities and still provide improved deliverability for the scaffold system to improve acute performance, degrade within 1 year, and potentially reduce long term MACE and stent thrombosis. DESolve Cx scaffolds thus become more user-friendly, enabling cardiologists to address the needs of a broader patient population.
“The excellent live case demonstration of DESolve Cx featuring outstanding deliverability, overexpansion and self-correction in case of strut malapposition reinforces Elixir’s commitment of providing cardiologists with the world’s first fully bioresorbable scaffold that presents another option to market-leading coronary drug eluting stents and ensure its greater adoption in everyday clinical practice,” said Motasim Sirhan, CEO of Elixir Medical. “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 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 (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.