US firm STAAR Surgical has obtained regulatory clearance from the Japanese Ministry of Health, Labour and Welfare to market its Visian implantable collamer lens (ICL) with CentraFLOW technology.
The regulatory clearance for the Visian ICL with CentraFLOW will now be expanded to include not only the technology, but also expands the treatment of myopic down to -3.0 diopters as compared with the current range which starts at -5.0 diopters.
CentraFLOW technology optimises fluid flow in the eye by using the KS-AquaPORT technology in the centre of the ICL optic.
CentraFLOW also removes the requirement for a YAG peripheral iridotomy surgical procedure days before the ICL implant, ultimately providing comfort and convenience to patients.
Staar Surgical president Asia Pacific region Don Todd said: "The CentraFLOW technology approval expands the treatment range so that surgeons in Japan will be able to treat patients with myopia starting at 3.0 diopters.
"Dr Shimizu’s early work on the KS-AquaPORT concept was very important to the success of this product."
Approximately 50,000 implants of the Visian CentraFLOW technology have been successfully performed worldwide.
The approved treatment range for the Visian ICL with CentraFLOW is -3.0 diopters to -18 diopters of myopia and the same spherical range for the Visian Toric ICL with CentraFLOW and from +1.0 diopters to +4.5 diopters of astigmatism.
In August 2013, the company obtained regulatory clearance in India for Visian ICL with CentraFLOW.
Staar Surgical president and CEO Barry G Caldwell said: "On behalf of STAAR and all the patients who will enjoy premium visual results with the Visian ICL CentraFLOW with KS-AquaPORT, I would like to thank Dr Shimizu for his pioneering work on this technology."
According to GlobalData estimates, the refractive surgery devices market in Japan was valued at $170.3m in 2012 and is expected to grow at a CAGR of 1.7% to reach $191.2m by 2019.
Image: Visian implantable collamer lens (ICL) model. Photo: courtesy of Greenteamochees.