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STAAR Toric ICL receives European marketing approval
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LONDON — The European Agency for the Evaluation of Medical Products has granted marketing approval for the toric version of the Implantable Contact Lens. The Toric ICL uses the same lens design as the spherical ICL, but employs a toric optic for correction of astigmatism.
According to Darcy Smith, vice president of refractive business for STAAR Surgical, makers of the lens, the approval for the Toric ICL was granted following a retrospective evaluation demonstrating excellent rotational stability.
Ms. Smith explained that safety and efficacy for the spherical ICL has been well demonstrated in previous trials and the company only needed to demonstrate rotational stability for the toric version.
“The toric optic has been added to our latest ICL design, version 4. V4 has shown statistically significant improved outcomes over the V3 lens as published in the Journal of Refractive Surgery (Nov-Dec 2002),” Ms. Smith said.
Rotational stability was demonstrated through evaluation of a series of slit lamp photographs taken on postoperative day 1 and at 3 months, 6 months and 1 year.
Both the spherical ICL and the toric version remain in clinical trials in the United States. The spherical ICL completed enrollment in November 1999, and the company expects to submit its pre-market approval application to the United States Food and Drug Administration shortly.
“The fact that it received the CE mark is a milestone for this product,” John A. Vukich, MD, the medical monitor for all U.S. clinical trials of the ICL, told Ocular Surgery News. “The fact that it is able to correct virtually all refractive errors really makes it a robust option for patients who previously may not have benefited from refractive surgery.”
For Your Information:
- Darcy Smith, vice president of refractive business for Staar Surgical, can be reached at 1911 Walker Ave., Monrovia, CA 91016; (626) 303-7902; fax: (626) 358-3049.
- John A. Vukich, MD, can be reached at Davis Duehr Dean Center for Refractive Surgery, 1025 Regent St., Madison, WI 53715; (608) 282-2000; fax: (608) 282-2048.
- STAAR Surgical, manufacturer of the Implantable Contact Lens and the Toric Implantable Contact Lens, can be reached at 1911 Walker Ave., Monrovia, CA 91016; (626) 303-7902; fax: (626) 358-9187.