|
| [November 09, 2012] |
 |
First 29 Cases Treated in US Clinical Trial of New Minimally Invasive, All-Femto Laser Vision Correction Method
DUBLIN, Calif. & JENA, Germany --(Business Wire)--
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
fromCarl 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 market introduction."
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.
Brief profile
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

[ Back To Technology News's Homepage ]
|