Following clearances from South Korea’s KFDA and Argentina’s ANMAT agencies, the company expects Visian ICL’s position in the surgical vision correction market to grow further.
The regulatory clearances for the Visian ICL with CentraFLOW will now be expanded from -0.5 diopter to -18.0 diopters on the myopic range and +0.5 cylinder power to +6.0 for the Toric ICL models.
Utilising the KS-AquaPORT technology in the center of the ICL optic, the CentraFLOW technology optimises fluid flow in the eye.
CentralFLOW also removes the requirement for a YAG peripheral iridotomy surgical procedure days before the ICL implant, ultimately providing comfort and convenience to patients.
So far in Europe, about 20,000 implants of the Visian CentraFLOW technology have been performed.
Commenting on the approval in South Korea, Staar Surgical Asia Pacific region president Don Todd said; "The refractive procedure market in Korea is both significant and fast growing, so this represents a very important milestone for us."
The company intends to train 100 surgeons on the new technology through a launch symposium to be held in South Korea on 27 July.
According to Staar Surgical, its Korean distributor Woo Jeon VT has been successful in driving the ICL market share in the country to more than 12% of all refractive procedures.
Commenting on the approval in Argentina, STaar Surgical EMEA, Latin America president Hans Blickensdoerfer said; "The approval of the Visian CentraFLOW technology means opening up the refractive market to further expand penetration into a significantly wider approval range."
In fiscal 2012, the ICL had about 7% share of all refractive procedures in the country.
According to a Market Scope 2013 comprehensive report on the global refractive surgery market, about 138,000 and 22,000 refractive procedures were performed in South Korea and Argentina respectively in fiscal 2012.