New Visian(R) ICL Products Gain CE Mark Approval
MONROVIA, Calif., May 20 /PRNewswire-FirstCall/ — STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced CE Mark approval for a range of product improvements to the Company’s Visian Implantable CollamerÃ‚® Lens (ICL(TM)) that more than doubles the current Visian addressable market in Europe. Included in the approval, STAAR Surgical received CE Mark approval for a Hyperopic Toric ICL which is designed for patients with both hyperopia, as well as astigmatism. Patients with hyperopia often referred to as farsightedness; have difficulty focusing on objects that are close up. Astigmatism is usually caused by an irregularly shaped cornea that causes blurred vision. Such patients are beyond the effective reach of existing surgical technologies and the Visian is the only option which will allow for the treatment of both conditions with one procedure.
“We believe these expanded offerings will provide the broadest correction approval of any refractive technology for surgeons in countries where the CE Mark applies and will allow the surgeon to treat virtually any patient who is a candidate for refractive surgery,” said STAAR Surgical CEO Barry G. Caldwell. “This approval will now allow surgeons to treat myopic patents from -0.5D to -2.75D with the new Visian ICL, hyperopic patients from +0.5D to +2.75D with the new Hyperopic ICL and both myopic and hyperopic astigmatic patients with up to 6 diopters of astigmatism. The addition of quarter diopter increments for low myopes (-0.5D to -2.75D) and low hyperopes (+0.5D to +2.75D) should optimize refractive targeting the sweet spot of the LASIK range and allow the surgeon to deliver an even more customized solution. STAAR is committed to the continuous improvement and expansion of patient benefits offered by the Visian ICL product line and additional Visian ICL features are in our pipeline. Our goal is to continue to offer new technology benefits in order to maintain the Visian ICL’s leadership role in the refractive lens market.”
With the CE Mark approval STAAR Surgical now offers Visian ICLs in the applicable countries ranging from myopic ICLs at -18.0D to hyperopic ICLs at +10.0D without interruption. Additionally STAAR can offer Visian Toric ICLs up to 6.0 diopters of cylinder for the entire range. For diopter ranges between -3.0D and +3.0D, the CE Mark approval has been expanded to quarterly increments from the previous 0.5 increments. Specifically, diopter range of ICL models will be extended to now cover the following diopters:
- Positive spheric, 0.25D increments from +0.5D to +2.75D, 0.5D increments from +3.0D to +10.0D.
- Negative spheric, 0.25D increments from -0.5D to -2.75D, 0.5D increments from -3.0D to -18.0D.
- Toric addition, 0.5D increments from +0.5D to +6.0D for all diopters from -18.0D to +10.0D, excluding quarter diopters, including 0.0D.
In addition to the expanded diopter range and Hyperopic Toric CE Mark approval, STAAR Surgical also designed several enhancements that increase physician ease of use of the Visian ICL during implant. These improvements include: the addition of perforating holes in the lens haptic to assist with removal of viscoelastics, improved lubricity on injector cartridges for ease of insertion, and new laser marks for the TICL designed to improve the surgeon’s ability to see the axis during and after implantation.
“We’ve also been approved to begin packaging Visian ICL products for CE markets in BSS, Balanced Salt Solution, which is the same storage medium for product marketed in the U.S. We will also be submitting data to improve the current two-year shelf life to five years. These approvals are the first step toward allowing us to move our global refractive business to a unified platform that should lead to greater manufacturing efficiencies,” added Mr. Caldwell.
STAAR Surgical first received CE Marking for the ICL in 1997, indicating the product is approved by the European Union (EU) and by other countries that recognize the CE Mark.
About STAAR Surgical
STAAR, which has been dedicated solely to ophthalmic surgery for over 25 years, designs, develops, manufactures and markets implantable lenses for the eye. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. A lens used to replace the natural lens after cataract surgery is called an intraocular lens or “IOL.” A lens used in refractive surgery as an alternative to LASIK is called an Implantable CollamerÃ‚® Lens or “ICL.” Over 150,000 Visian ICLs have been implanted to date; to learn more about the ICL go to: www.visianinfo.com. STAAR has approximately 300 full time employees and markets lenses in approximately 50 countries. Headquartered in Monrovia, CA, it manufactures in the following locations: Nidau, Switzerland; Ichikawa City, Japan; Aliso Viejo, CA; and Monrovia, CA. For more information, please visit the Company’s website at: www.staar.com or call 626-303-7902.
CollamerÃ‚® is the registered trademark for STAAR’s proprietary biocompatible collagen copolymer lens material.
All statements in this press release that are not statements of historical fact are forward-looking statements, including any statements about the effect of new product approvals on our business, any statements of belief and any statements of assumptions underlying any of the foregoing.
These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties include the following: the negative effect of the global recession on sales of products, especially products such as the ICL used in non-reimbursed elective procedures; the challenge of managing our foreign subsidiaries; the willingness of surgeons and patients to adopt a new product and procedure; the entrenched market position of laser-based procedures for many conditions treated by the Visian ICL, patterns of Visian ICL use that have typically limited our penetration of the refractive surgery market, and the potential effect of recent negative publicity about LASIK on the demand for refractive surgery in general in the U.S. STAAR assumes no obligation to update its forward-looking statements to reflect future events or actual outcomes and does not intend to do so.
CONTACT: Investors Media EVC Group EVC Group Doug Sherk, 415-896-6820 Christopher Gale, 646-201-5431
SOURCE STAAR Surgical Company