FDA approves larger size corneal implants for keratoconus
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DES PLAINES, Ill. Addition Technology has received U.S. Food and Drug Administration approval for an expanded range of additional sizes of Intacs corneal implants for keratoconus, the company announced in a press release.
The availability of larger size implants will allow physicians to delay or avoid corneal transplants in some keratoconic patients.
"As a company, we have been studying and surveying the keratoconus market for more than 10 years," William M. Flynn, president and CEO of Addition Technology, said in the release. "We have learned that surgeons need more options when dealing with these unique and challenging cases. The expansion in our product offering will go a long way toward addressing this need on behalf of the surgeon and their patients."
"Our colleagues in Europe have been presenting data for over 10 years regarding the benefits of the larger sizes," David J. Schanzlin, MD, said in the release. "Based on the impressive results they have reported, I view this as an important breakthrough in addressing keratoconus, particularly in younger people where a transplant may not always be the first option."
Dr. Schanzlin is one of the original FDA medical monitors and the first U.S. surgeon to work with Intacs for keratoconus pioneer Joseph Colin, MD.
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