CE Marks for STAAR

May 4, 2011

STAAR Surgical Co. has received CE Mark approval for a single-piece IOL (nanoFLEX Collamer) and the V4c design of its implantable contact lens ([ICL]; Visian Implantable Collamer Lens). ^ CE mark approval allows the company to market the products in the European Economic Area (EEA) and can serve as a foundation for additional approvals in countries outside the EEA.

Monrovia, CA-STAAR Surgical Co. has received CE Mark approval for a single-piece IOL (nanoFLEX Collamer) and the V4c design of its implantable contact lens ([ICL]; Visian Implantable Collamer Lens). CE Mark approval allows the company to market the products in the European Economic Area (EEA) and can serve as a foundation for additional approvals in countries outside the EEA.

The single-piece IOL, which surgeons can inject through a 2.2-mm incision using a proprietary injector system (nanoPOINT), incorporates the company’s proprietary, patent-pending aspheric optic design for the naturally curved anatomy of the eye. The company is changing the IOL’s design “to further enhance near and intermediate visual results,” said Barry G. Caldwell, STAAR Surgical chief executive officer, and is planning to package this lens and the toric version in a new, preloaded injection system.

The new design of the ICL, included in both myopic and myopic toric models, incorporates a proprietary port in the center of the lens optic of a size designed to optimize the flow of fluid within the eye. It eliminates the need for surgeons to perform YAG peripheral iridotomies before lens implantation. The company has received two patents on the technology to enhance flow within the eye and is pursuing additional claims to broaden its intellectual property position further.

The V4c model has been approved in the –0.5 to –18.0 D myopic range and +0.5 D cylinder power to +6.0 D for the toric ICL models. The company plans to do a pre-market release of the product in four sites and 100 eyes before fully launching the products in markets that accept CE mark approvals. In some Asia Pacific markets that have not yet launched the V4b model introduced late last year, the company plans to seek approval of the V4c model and move directly to this model.

The V4b model expanded the range of approved treatment zones on the myopic, hyperopic, and toric models of the ICL, according to Caldwell. “The V5 model is currently under way with our research and development team, and the concept designs for the V6 model are in the feasibility phase,” he said.