ZEISS Receives FDA Approval for ReLEx SMILE

Jena/Germany  | Carl Zeiss Meditec AG

Today, the ZEISS Medical Technology Segment announced the FDA Premarket Approval (PMA) for ReLEx^® SMILE^® PMA 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 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.

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 outstanding cutting precision, exceptional speed and gentle treatment make it an ideal platform for advanced corneal surgery such as SMILE^®. Incisions are made through microscopic-photodisruptions of tissue, created by ultrashort pulses.

Many patients are patiently awaiting this approval, reported John F. Doane, M.D., F.A.C.S. of Discover Vision Centers. “We and our patients are excited to say the least. Refractive surgery just keeps getting better with Carl Zeiss Meditec’s FDA approval of SMILE^® for compound myopic astigmatism,” Doane added.

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.

Refractive surgeons benefit from SMILE^®’s versatility, offering patients a more comfortable treatment option. 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,” said Dr. Ludwin Monz, President, and CEO of Carl Zeiss Meditec. “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. The technology behind SMILE was recently featured in the Scientific Background on the Nobel Prize in Physics 2018. Dr. Gérard Mourou and Dr. Donna Strickland were awarded the Nobel Prize for their 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. ReLEx® SMILE® is a registered trademark of Carl Zeiss Meditec. For more information about ReLEx^® SMILE^®, visit www.zeiss.com.