FDA Approves EXCELLA III Trial of Elixir's Desyne Nx Stent

May 8, 2013—Elixir Medical Corporation (Sunnyvale, CA) announced that it has received approval from the US Food and Drug Administration (FDA) to initiate patient enrollment in the EXCELLA III clinical trial at up to 50 institutions the United States. EXCELLA III will enroll patients with conditions to be addressed in parallel.

The company advised that results from the EXCELLA III pivotal trial will be used to support a future premarket approval application to the FDA for the company's Desyne Nx novolimus-eluting coronary stent system. The Desyne Nx stent is designed to treat heart vessel blockages by eluting a low dose of novolimus, an active metabolite of sirolimus, via an ultrathin, durable coating.

According to Elixir's press release, 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, Inc., Minneapolis, MN) as a control in a 2:1 randomization of 2,051 patients recruited from centers in the United States and internationally.

The primary endpoint of the EXCELLA III trial is target lesion failure, which is 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. In addition, a subset of patients will be evaluated for angiographic endpoints, and all patients will be followed for 5 years. Martin B. Leon, MD, is the principal investigator for the EXCELLA III study.

“EXCELLA III will be a promising trial building upon the excellent and sustained clinical outcomes of the EXCELLA II trial,” commented Dr. Leon in the company's press release. “I am excited about Desyne Nx's potential to validate the safety and long-term performance in this large clinical trial.”

The company stated that investigational device exemption approval for the EXCELLA III trial in the United States 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 in October at the TCT 2012: Transcatheter Cardiovascular Therapeutics conference in Miami, Florida. In EXCELLA II, the Desyne stent demonstrated both noninferiority and superiority to the zotarolimus-eluting control stent for the primary endpoint of in-stent late lumen loss and achieved a low clinical event rate through 3 years. The data collected from the global use of Desyne will be used to supplement the future premarket approval application in the United States for the Desyne Nx novolimus-eluting coronary stent system, stated the company.