Carl Zeiss Meditec announced its intention to initiate a U.S. clinical trial of the ReLEx smile procedure for the correction of myopia, having received conditional approval for the trial from the FDA.
Chicago-Carl Zeiss Meditec announced its intention to initiate a U.S. clinical trial of the ReLEx smile procedure for the correction of myopia, having received conditional approval for the trial from the FDA.
Carl Zeiss Meditec developed the new ReLEx smile technique for refractive surgery, which combines femtosecond laser technology and precise lenticule extraction for minimally invasive laser vision correction-all in a single system (VisuMax Femtosecond Laser).
The ReLEx smile method generates a refractive lenticule in the intact cornea with the femtosecond laser. The surgeon then removes the lenticule through a less-than-4-mm 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 United States,” said Ludwin Monz, PhD, president and chief executive officer of Carl Zeiss Meditec AG.
The VisuMax Laser Keratome is currently cleared in the United States for creating corneal flaps as well as for lamellar and penetrating keratoplasty for corneal transplantations. VisuMax ReLEx smile was launched internationally in September 2011.
Conditional approval to initiate the clinical trial was received April 20. Carl Zeiss Meditec is expecting to start enrolling patients in the U.S. clinical trial within the next few months.
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