First 29 Cases Treated in US Clinical Trial of New Minimally Invasive,
All-Femto Laser Vision Correction Method
One month results will be presented at a Carl Zeiss symposium at AAO 2012
DUBLIN, Calif. & JENA, Germany -- November 09, 2012
Carl Zeiss Meditec announced that the first 29 subjects in the VisuMax IDE
clinical trial in the US have been treated with the ReLEx^® smile procedure
for the correction of spherical myopia with the VisuMax^® femtosecond laser.
One month results for the first 15 subjects will be presented at a Carl Zeiss
Meditec symposium at the 2012 American Academy of Ophthalmology Annual Meeting
in Chicago. The company received conditional approval from the US FDA to
initiate the clinical trial in April 2012.
Jon Dishler, MD, the Medical Monitor for the United States VisuMax clinical
trial and the first study site to initiate treatments using the ReLEx smile
procedure, had the following comment, “My perception is that the ReLEx smile
procedure is the first significant innovation in laser vision correction since
it became popular almost 20 years ago. Based on positive international
experience, we are pleased to have been chosen to lead the US clinical trial
of this procedure. We look forward to reporting our results, along with those
of the other investigators.”
ReLEx smile is laser vision correction by small incision lenticule extraction
and was developed by Carl Zeiss Meditec for refractive surgery. The procedure
combines femtosecond laser technology and precise lenticule extraction for
minimally invasive laser vision correction for the first time – all in a
single system: the VisuMax Femtosecond Laser from Carl Zeiss Meditec. While in
LASIK procedures the excimer laser vaporizes tissue, the ReLEx smile method
generates a refractive lenticule in the intact cornea with the femtosecond
laser. The surgeon then removes the lenticule through a small,
less-than-four-millimeter incision without needing to move the patient to an
excimer laser. “With the first results of the clinical trial of ReLEx smile in
the US, we take further steps to make this procedure available to surgeons in
the US,” says Dr. Ludwin Monz, President and CEO of Carl Zeiss Meditec AG.
“This progress underlines the promising development in the first year after
ReLEx smile, which is the first small incision, single-step and all-femto
vision correction method, was launched internationally in September 2011. It
is already launched in key markets such as Europe, China and India. About 60
clinicians globally perform the procedure today and more than 12,000 eyes have
been treated so far.
Carl Zeiss Meditec AG (ISIN: DE0005313704), which is listed on TecDax of the
German stock exchange, is one of the world’s leading medical technology
companies. The company supplies innovative technologies and
application-oriented solutions designed to help doctors improve the quality of
life of their patients. It provides complete packages of solutions for the
diagnosis and treatment of eye diseases, including implants and consumables.
The company creates innovative visualization solutions in the field of
microsurgery. The medical technology portfolio of Carl Zeiss Meditec is
rounded off by promising, future-oriented technologies such as intraoperative
radiotherapy. In fiscal year 2010/11 (ended 30 September) the company's around
2,400 employees generated revenue of EUR 759 million.
The head office of Carl Zeiss Meditec is in Jena, Germany. The company has
subsidiaries in Germany and abroad; more than 50 percent of its employees are
based in the USA, Japan, Spain and France. The Center for Research and
Development (CARIn) in Bangalore, India and the Carl Zeiss Innovations Center
for Research and Development in Shanghai, China, strengthen the presence in
these rapidly developing economies. 35 percent of Carl Zeiss Meditec shares
are in free float. The remaining 65 percent are held by Carl Zeiss AG, one of
the world’s leading groups in the optical and optoelectronic industries. Carl
Zeiss offers innovative solutions for the future-oriented markets of Medical
and Research Solutions, Industrial Solutions, Eye Care and Lifestyle Products.
Carl Zeiss AG, Oberkochen, is fully owned by the Carl Zeiss Foundation.
For more information, please go to: www.meditec.zeiss.com
Jann Gerrit Ohlendorf, Director Corporate Communications, Carl Zeiss Meditec
+49 36 41 220-331
Henriette Meyer, Director Investor Relations, Carl Zeiss Meditec
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