US FDA conditional approval received to initiate a clinical trial of the ReLEx® smile procedure for the correction of myopia with the VisuMax® Femtosecond Laser
Carl Zeiss Meditec announced its intention to initiate a US clinical trial of the ReLEx smile procedure for the correction of myopia, having received conditional approval for the trial from the US Food and Drug Administration (FDA).
Carl Zeiss Meditec has developed the new ReLEx smile technique for refractive surgery, which 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. "We are pleased that we can now start this clinical trial as it represents the first milestone on our path to make this procedure available to surgeons in the US," says Dr. Ludwin Monz, President and CEO of Carl Zeiss Meditec AG.
The VisuMax Laser Keratome is currently cleared in the US for creating corneal flaps as well as for lamellar and penetrating keratoplasty for corneal transplantations. VisuMax ReLEx smile, which is the first small incision, single-step and all-femto vision correction method, was launched internationally in September 2011.
Conditional approval to initiate the clinical trial was received on April 20, 2012. Carl Zeiss Meditec is expecting to start enrolling patients in the US clinical trial within the next few months.
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 suppliers. 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 2010/2011 (30 September) financial year the approx. 2,400 employees generated revenue of € 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. Thirty-five 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 opto-electronics industry. Carl Zeiss offers innovative solutions for the future-oriented markets of Industrial Solutions, Research Solutions, Medical Technology and Consumer Optics. In fiscal year 2010/11 the company's approx. 24,000 employees generated revenue of about 4.237 billion euros. Carl Zeiss AG is wholly owned by the Carl Zeiss Stiftung (Carl Zeiss Foundation). Founded in 1846 in Jena, the company is headquartered in Oberkochen, Germany.
For further information see: www.meditec.zeiss.com
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Contacts:
Carl Zeiss Meditec AG
Petra Rettenmaier, +49 36 41 220-331
Director
Corporate Communications
press@meditec.zeiss.com
Alice
Swinton, +1-925-557-4317
Director Marketing Communications
a.swinton@meditec.zeiss.com
www.meditec.zeiss.com/press
