Carl Zeiss Meditec has secured approval from the US Food and Drug Administration (FDA) for its ReLEx Smile, expanding myopia treatment to patients with astigmatism.
ReLEx SMILE was introduced in the US in 2016. In the last 10 years, more than 1.5 million SMILE treatments have been performed globally constituting over 10% of worldwidelaser vision correction procedures.
The FDA’s premarket approval also allows to make small entry incision, enabling Smile procedure to be less disruptive to the corneal surface tissue.
Carl Zeiss Meditec ophthalmic devices global president Jim Mazzo said: “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.”
ReLEx Smile uses the high-precision femtosecond laser VisuMax to form a lenticule inside the cornea and access incision in a single treatment step.
The ultrashort pulses will help create incisions through microscopic-photodisruptions of tissue.
VisuMax laser is claimed to be the first femtosecond laser to secure FDA PMA approval to treat refractive indication. It also secured 510(k) clearances for Lasik flap, keratoplasty, and ICR.
Carl Zeiss Meditec president and CEO Ludwin Monz said: “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.
“Now with the FDA approval for US SMILE Astigmatism, we can now extend this great treatment option to US Astigmatism patients as well.”
Carl Zeiss Meditec, which is a medical technology business group of Zeiss, supplies advanced technologies and application- oriented solutions for better treatment of patients.
The company’s solutions comprised of implants and consumables, which can be used to diagnose and treat eye diseases. It also provides advanced visualization solutions for use in the field of microsurgery.
The group manages Center for Application and Research (CARIn) in Bangalore of India, and Carl Zeiss Innovations Center for Research and Development in Shanghai of China.