Zeiss announced the FDA premarket approval for ReLEx SMILE to treat myopia with astigmatism. The premarket approval 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,” Jim Mazzo, Global President Ophthalmic Devices at Carl Zeiss Meditec, said in a company news release.
ZEISS ReLEx SMILE utilizes the high-precision femtosecond laser VisuMax to create a lenticule inside the cornea and access incision in a single treatment step. Its cutting precision, speed and gentle treatment make it an ideal platform for advanced corneal surgery such as SMILE, according to Zeiss. Incisions are made through microscopic-photodisruptions of tissue, created by ultrashort pulses.
“[The FDA approval] will greatly increase the applicability of SMILE because we know that a fair number of patients who seek laser vision correction who are eligible for SMILE have astigmatism,” Steven Schallhorn, MD, Chief Medical Officer at Zeiss, said in an interview with Eyewire News. “The approval was based on a very comprehensive study that was done in multiple centers in the United States that carefully and diligently looked at how well SMILE as a technique, as a procedure, can correct astigmatism. And we found that it was very effective.”
VisuMax laser is the first femtosecond laser to receive FDA PMA approval for the treatment of a refractive indication in addition to 510k clearances for LASIK flap, keratoplasty, and ICR. With the approval of ReLEx SMILE, patients can now benefit from a minimally invasive surgery, performed on one laser versus two. With the approved new indication range the surgeon has also the option to benefit from extended technical parameters.
“Thanks to our continued collaboration with partner surgeons worldwide, we are able to pave the way for new developments and technologies in the refractive space,” Dr. Ludwin Monz, President, and CEO of Carl Zeiss Meditec, said in the news release. “Now with the FDA approval for US SMILE Astigmatism, we can now extend this great treatment option to US Astigmatism patients as well.”
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% of global laser vision correction procedures. To date, there are over 1700 surgeons using SMILE in over 70 countries.