Carl Zeiss Meditec (Dublin, CA), the Medical Technology business group of Zeiss (Oberkochen, Germany), has received U.S. FDA premarket approval (PMA) for the ReLEx SMILE PMA ultrafast laser procedure, expanding myopia treatment to patients with astigmatism. 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 ReLEx SMILE procedure, which made its U.S. debut in 2016, uses the company's VisuMax femtosecond laser to create a lenticule inside the cornea and access incision in a single treatment step. Incisions are made through microscopic-photodisruptions of tissue, created by ultrashort pulses.
The VisuMax laser has already received U.S. FDA 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 vs. two.
VisuMax and ReLEx SMILE are registered trademarks of Carl Zeiss Meditec.
For more information, please visit www.zeiss.com/med.