DUBLIN, CA--(Marketwire - April 10, 2010) - ASCRS Booth #1103 -- Carl Zeiss Meditec today announced that ReLEx, the first femtosecond-only method of laser vision correction, is now available for sale outside the United States.1 ReLEx is a new application that allows ophthalmic surgeons to perform a variety of complete laser vision correction procedures using only the VisuMax® Femtosecond laser.
"After several years of clinical research and development, we are pleased to unveil the first femtosecond-only laser vision correction method as a completely new option in our Refractive Laser Solutions offering," said Ludwin Monz, CEO of Carl Zeiss Meditec. "Because the entire procedure can be performed on one advanced system, we are able to deliver unprecedented workflow benefits to the practice. We believe that providing refractive surgeons with a range of flexible treatment approaches allows them to select the most appropriate set of technologies for their surgical settings."
ReLEx is Carl Zeiss' brand name for complete laser vision correction procedures that can be performed entirely with the VisuMax® Femtosecond laser, such as the Femtosecond Lamellar Extraction (FLEx) method and the Small Incision Lamellar Extraction (SMILE) method. ReLEx uses precise laser cutting, while excimer LASIK uses ablation of tissue. Beyond ReLEx, with the VisuMax surgeons can perform lamellar keratoplasty, penetrating keratoplasty and tissue resection procedures as well as corneal flap cutting procedures.
ReLEx allows for very small flap sizes, typically just 0.5 to 1 mm larger in diameter than the optical zone. Furthermore, ReLEx provides an easier and much faster workflow for the surgeon as the entire procedure can be performed using a single laser. To date, ReLEx procedures have been performed on more than 1000 eyes at a variety of locations outside the U.S.
In a recent study in which the ReLEx Femtosecond Lamellar Extraction (FLEx) method was performed by Professor Osama Ibrahim, MD at ALEX Laser Center in Alexandria, Egypt, ReLEx compared favorably to LASIK in terms of efficacy, stability, and safety. 102 eyes, (71 female eyes and 31 male eyes) with myopia or myopic astigmatism with a spherical equivalent of -5.07 D +/- 2.77 D were treated. At the 3-month follow-up, 95 percent of eyes treated were within +/-1.00 D and 76 percent of eyes were within +/-0.50 D of intended correction. Mean spherical equivalent was -0.17 D +/- 0.64 D at 1 month. Stability was seen at one week postoperatively. A total of 85 percent of eyes achieved an uncorrected distance visual acuity (UDVA) of 20/20 or greater at 1 month and 84 percent of eyes showed UDVA of 20/25 or better at day one.
No change in corrected distance visual acuity (CDVA) was reported in 69 percent of eyes however, a gain of one or more lines was achieved in 9 percent of eyes. A loss of more than 2 lines occurred in 2 percent at 1 month.
"Until now, laser vision correction has been a two-part process in which the patient must be moved from one platform to another," said Professor Osama Ibrahim. "With ReLEx using the VisuMax Femtosecond Laser, I achieved consistently excellent visual outcomes while enhancing patient comfort, both of which are essential to achieve a high level of satisfaction in today's elective surgery environment."
Carl Zeiss Meditec continues to perform clinical research for the SMILE method (in which the corneal flap is eliminated). In this procedure, the VisuMax® creates a series of small incisions to allow for manual removal of the lamellar without cutting a conventional flap. This next evolution of ReLEx is expected to become commercially available internationally (outside of the United States) in 2011.
New data for the ReLEx procedure will be presented at Carl Zeiss Meditec's Refractive Solutions educational symposium on Monday, April 12 at 7:30 pm at Renaissance Boston Waterfront Hotel in Boston. Meeting delegates can register for this event and other events at www.meditec.zeiss.com/ascrs. Please visit the Carl Zeiss Meditec booth #1103 at the Boston Convention and Exhibition Center to preview the VisuMax Femtosecond laser at this year's ASCRS meeting.
Brief profile
Carl Zeiss Meditec AG (ISIN: DE 0005313704), 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 consumable materials.
The company creates innovative visualisation solutions in the field of microsurgery. Carl Zeiss Meditec's medical technology portfolio is rounded off by promising future technologies such as intraoperative radiation therapy.
In the financial year 2008/2009 (30 September) the 2,100 employees generated revenue of approximately EUR 640 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.
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 engaged in the optical and opto-electronics industry. Carl Zeiss offers innovative solutions for the future-oriented markets of "Medical and Research Solutions," "Industrial Solutions" and "Lifestyle Products." The head office of Carl Zeiss AG is in Oberkochen, Germany. In financial year 2008/09 (balance sheet date 30 September) the group posted sales of around EUR 2.1 billion. The Carl Zeiss Group has approximately 13,000 employees, including more than 8,000 in Germany.
Further information: www.meditec.zeiss.com
1The VisuMax Femtosecond laser is available for sale in the United States for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. The ReLEx method is not available for sale in the United States.
Contact Information:
Contacts:
Eva Sesselmann
Director Corporate Communications
Carl Zeiss Meditec AG
Göschwitzer Straße 51-52
07745 Jena, Germany
Phone: +49 3641 220-331
Fax: +49 3641 220-112
E-mail: