Japanese authorities have granted WaveLight AG regulatory approval to market its 200-Hz excimer laser system (Allegretto Wave) for use in wavefront-optimized LASIK treatments of myopia and myopic astigmatism there, according to the company.
-Japanese authorities have granted WaveLight AG regulatory approval to market its 200-Hz excimer laser system (Allegretto Wave) for use in wavefront-optimized LASIK treatments of myopia and myopic astigmatism there, according to the company. The approval process took almost 5 years, according to WaveLight.
The laser is designed to work at high pulse frequencies so that its corneal ablations minimize the dehydration of the eye and other external influences during surgery, according to the company. A spot size of 0.68 mm helps enable high precision, and the special ablation profiles allow large optical zones to be treated with small transition zones, according to WaveLight.
“We are very happy about this great success,” said Wolfgang Tolle, chief executive officer of the company. “The Japanese market, with its more than 200,000 refractive procedures per year, includes an enormous potential for WaveLight.”
In other news, WaveLight announced the performance of the first treatment with its new femtosecond laser (UltraFlap), which occurred during clinical testing approved by the German government.
Christoph Winkler von Mohrenfels, MD, performed the first flap cut at the Technical University of Munich. The patient undergoing LASIK showed no postoperative abnormalities, according to the company, and a smooth stromal bed and an easy-to-lift flap due to sharp cutting edges were observed.
“This step means a further important milestone in the development of our femtosecond laser,” Tolle said. “We are expecting to be able to offer a ready-for-sale product soon.”
In addition to the normal flap cut ability, WaveLight announced plans to add further fields of applications-related to sub-Bowman keratomileusis and intracorneal ring segments, as well as lamellar, penetrating and self-sealing keratoplasty-to the new femtosecond laser system.