FDA clears Eva Nexus subretinal injection system
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DORC International has received FDA 510(k) clearance for Eva Nexus, the first surgical system cleared for subretinal injection, according to a press release.
The system includes a Smart IOP infusion mode that allows surgeons to work at lower infusion pressures while maintaining a stable anterior and posterior chamber, the DORC trocar cannula system with Hi-Flow infusion line, and the Eva Inicio microinjection system.
Other improvements include detection of balanced salt solution level, a vertical and horizontal adjustable monitor, digital surgical overlay, and a foot brake to reposition and lock the system.
“510(k) approval for Eva Nexus is another major milestone for DORC,” Pierre Billardon, CEO of DORC, said in the release. “Already used for over 4,000 cases in Europe including a randomized controlled trial, Eva Nexus now brings next-generation technology to U.S. surgeons.”
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Press Release
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