Zeiss Receives FDA Approval for ReLEx SMILE Myopia Treatment
Monday, October 8, 2018 12:27 AM
DUBLIN, Calif.—The ZEISS
Medical Technology Segment announced Friday that has received FDA Premarket Approval (PMA) for ReLEx SMILE, expanding myopia treatment to patients with astigmatism. Small Incision Lenticule Extraction, better known as ReLEx SMILE
from Zeiss is a minimally-invasive corneal refractive procedure performed on the Zeiss VisuMax
femtosecond laser. The PMA also provides for a small entry incision to be made, allowing the SMILE procedure to be potentially less disruptive to the corneal surface tissue.
“The expansion of myopia treatment to patients with astigmatism will enable current and future Smile surgeons to expand their patient base, paving the way for a new generation of refractive surgery patients,” said Jim Mazzo, global president ophthalmic devices at Carl Zeiss Meditec.
ReLEx SMILE from Zeiss made its U.S. debut in 2016. In the last 10 years, over 1.5 million Smile treatments have been performed worldwide constituting over 10 percent of global laser vision correction procedures. To date, there are over 1,700 surgeons using Smile in over 70 countries. The technology behind Smile was recently featured in the Scientific Background on the Nobel Prize in Physics 2018. Dr. Gerard Mourou and Dr. Donna Strickland were awarded the Nobel Prize for his method to generate high-intensity ultrashort optical pulses. Their invention of so-called chirped pulse amplification is essential to generate the ultrashort laser pulses of the Zeiss VisuMax femtosecond laser system.