Elixir Medical has received the US Food and Drug Administration’s (FDA) nod to begin the process of enrolling patients in its EXCELLA III clinical trial of its DESyne Nx Novolimus eluting coronary stent system.
The FDA’s Investigational Device Exemption (IDE) will allow the company to enrol 2,051 patients for the randomised, controlled trial at up to 50 institutions in the US, as well as international centres, with conditions to be addressed in parallel.
The DESyne Nx stent is said to treat heart vessel blockages, while eluting a low dose of the company’s proprietary drug Novolimus, an active metabolite of sirolimus, through an ultrathin durable coating.
With the help of the prospective, controlled, multicentre, single-blind study, Elixir aims to compare DESyne Nx to the Resolute Zotarolimus eluting coronary stent system, developed by Medtronic Vascular, in a 2:1 randomisation of enrolled patients.
FDA clearance follows the CE mark approval, which was previously awarded to DESyne in Europe based on EXCELLA II trial results, and the subsequent international commercial launch.
Principal Investigator for the proposed study Dr Martin Leon said; "I am excited about DESyne Nx’s potential to validate the safety and long-term performance in this large clinical trial".
EXCELLA II, conducted on 210 patients at 22 clinical centers in Europe, Australia, New Zealand and Brazil, 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 all three years of follow-up.
The new study, primary endpoint of which will be target lesion failure (TLF), enrolls a subset of patients to evaluate for angiographic endpoints, and follows up with all the patients for five years.
Elixir plans to use both EXCELLA III results and the data collected from the global use of DESyne to support a future Pre-Market Approval (PMA) application in the US.
Elixir Medical chief executive officer Motasim Sirhan said IDE approval for DESyne Nx is an important milestone towards the company’s objective to bring its product portfolio to patients globally.
"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 Sirhan.