With a green-light from the FDA, Elixir Medical Corporation will move forward with its Excella III pivotal trial to review its DESyne Nx Novolimus-eluting coronary stent system. Elixir plans to enroll patients at 50 clinical locations and will use the trial results to support its upcoming premarket approval application.
The Excella III study will compare DeSyneNx treatment to Medtronic’s (NYSE:MDT) Resolute Zotarolimus-eluting coronary stent system. Results in the Excella II trial last year resulted in CE Mark approval for Elixir’s treatment.
This treatment breaks up heart vessel blockages by emitting a low dose of Novolimus through a thin coating in the stent system. The primary goal of this study, which will include more than 2,050 patient from the U.S. and abroad, is to measure target lesion failure.
"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 CEO Motasim Sirhan in prepared remarks. "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."