To receive NTIOL recognition, an IOL must first be an FDA approved IOL with labeling and advertising consistent with the specific claim or characteristic for which CMS approval is being sought. In addition, there must be evidence that the use of the IOL results in measurable, clinically meaningful improved patient outcomes in comparison with use of currently available IOLs. The Afinity Collamer Aspheric IOL has proven to reduce spheric aberrations, leading to improved visual acuity and increased contrast sensitivity.
The NTIOL subset for Reduced Spherical Aberrations to which the STAAR Afinity Collamer Aspheric IOL has been approved allows for enhanced reimbursement beginning March 17, and extends through Feb. 26, 2011.
“STAAR is very pleased that CMS has recognized the benefits of the Collamer material in our three-piece Aspheric IOL,” says Barry G. Caldwell, the president and CEO of Staar Surgical, in a statement. “This approval will allow us to compete more effectively in the market while increasing our average selling price which will assist in our gross margin improvement efforts. This is the first step in our plans to refresh our entire U.S. cataract product offerings.”
Exclusive to Staar, Collamer is a unique lens material that is composed of collagen, a UV-absorbing chromophore, and a poly-HEMA-based copolymer. The Afinity Collamer Three-Piece Aspheric IOL, which has a square posterior and rounded anterior edges, combines foldable IOL technology with traditional design and achieves significant biocompatibility, according to the company. The IOL has modified C-loop polyimide haptics with five degrees of angulation, letting it offer flexibility comparable to polypropylene and PMMA haptics, along with greater tensile strength, and superior shape memory, says Staar Surgical.
“The next milestone will be our new nanoPoing delivery system, which can inject the current Collamer Single Piece IOL through a 2.2mm incision, as compared to the current requirement of a 2.8mm to 3.0mm incision,” says Mr. Caldwell. “This smaller incision size will help reduce surgically induced astigmatism, improve chamber maintenance during the surgical procedure and reduce healing time for the patient. The nanoPOINT injector is currently in pre-release marketing evaluations. The next steps include additional NTIOL submissions followed with clear regulatory pathways for the Collamer Aspheric Single Piece IOL, additional improved delivery systems, the Collamer Toric IOL, and the preloaded silicone IOL offerings.”
