VisiJet Inc. has received FDA approval for its EpiLift System, an ophthalmic surgical device designed for separating corneal tissue.
ParisVisiJet Inc. has received FDA approval for its EpiLift System, an ophthalmic surgical device designed for separating corneal tissue.
"The EpiLift System provides a revolutionary new method to perform refractive surgery," said Randy Bailey, president and chief executive officer of VisiJet. "The EpiLift System will make Epi-LASIK a mainstay procedure for the correction of myopia, hyperopia, and astigmatism. It provides the safety, control, and better visual outcomes vital to both physician and consumer acceptance."
During the Epi-LASIK procedure, the corneal epithelium is separated into an intact sheet of viable tissue. This tissue, the Epi sheet, is lifted temporarily away from the cornea so that a laser can be applied to reshape the corneal bed. Once this is completed, the epithelial sheet is returned to its natural position on the eye.
By eliminating the cutting of stromal flaps (as in traditional LASIK), the EpiLift System eliminates the primary cause of LASIK complications, according to the company.
With FDA approval, the company expects domestic sales to be significant due to the strong interest shown in the technology by U.S. refractive surgeons.
"The EpiLift System provides us with another entry into the $4 billion worldwide refractive surgery market," Bailey said. He noted that the new EpiLift technology joins the company's proprietary waterjet technologies that are in final development stages.
VisiJet Inc. received the CE Mark for the EpiLift System earlier this year.