Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced today that it has received approval from the Food and Drug Administration (FDA) to initiate patient enrollment in the EXCELLA III clinical trial in the United States at up to 50 institutions with conditions to be addressed in parallel. Results from the EXCELLA III pivotal trial will be used to support a future Pre-Market Approval (PMA) application in the US for the DESyne® Nx Novolimus Eluting Coronary Stent System.
“I am excited about DESyne Nx's potential to validate the safety and long-term performance in this large clinical trial.”
The DESyne Nx Stent, designed to treat heart vessel blockages, elutes a low dose of Elixir's proprietary drug Novolimus, an active metabolite of sirolimus, via an ultrathin durable coating. The EXCELLA III clinical trial will be a prospective, controlled, multicenter, single-blind study comparing DESyne Nx to the Resolute Zotarolimus Eluting Coronary Stent System (Medtronic Vascular, Santa Rosa, CA, USA) as control in a 2:1 randomization of 2,051 patients recruited from US and International centers. The Principal Investigator for the EXCELLA III study is Martin B. Leon, M.D., New York - Presbyterian Hospital / Columbia University Medical Center, New York, NY.
The IDE approval for the EXCELLA III trial in the US follows the successful international commercial launch of DESyne which gained CE Mark approval based on the results of the EXCELLA II trial. The EXCELLA II trial was a randomized controlled study that enrolled 210 patients at 22 clinical centers in Europe, Australia, New Zealand, and Brazil. The 3-year follow-up results were presented last October at the Transcatheter Therapeutics (TCT) Conference in Washington, D.C. The DESyne stent demonstrated both non-inferiority and superiority to the Zotarolimus-Eluting control stent for the primary endpoint of in-stent late lumen loss and achieved low clinical event rate through 3 years. The data collected from the global use of DESyne will be utilized to supplement the future Pre-Market Approval application in the US for the DESyne® Nx Novolimus Eluting Coronary Stent System.
"EXCELLA III will be a promising trial building upon the excellent and sustained clinical outcomes of the EXCELLA II trial," said Dr. Leon. "I am excited about DESyne Nx's potential to validate the safety and long-term performance in this large clinical trial."
The primary endpoint of the EXCELLA III trial is target lesion failure (TLF), a composite measure of safety and effectiveness at 12 months defined as cardiac death, myocardial infarction related to the target vessel, and clinically-indicated target lesion revascularization (TLR). In addition, a subset of patients will be evaluated for angiographic endpoints, and all patients will be followed for five years.
"We are excited to bring into the United States the next-generation DES that successfully combines the thinnest durable polymer coating with the lowest drug dose and thin stent struts for clinical evaluation," said Motasim Sirhan, Chief Executive Officer of Elixir Medical. "Elixir's goal is to bring its excellent and comprehensive product portfolio to patients globally, and the IDE approval for DESyne Nx is an important milestone towards this objective."
SOURCE Elixir Medical Corporation