Victus Femtosecond Laser Platform Receives FDA Clearance
From EyewireToday.com — 8/6/2012
FDA Approval/Clearance
The Victus Femtosecond Laser Platform (Bausch + Lomb and Technolas Perfect Vision GmbH) received 510(k) clearance from the FDA for creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea, and anterior capsulotomy during cataract surgery. The platform is now commercially available in the United States.
The Victus platform is the first femtosecond laser capable of supporting cataract and corneal procedures on a single platform, according to a Bausch + Lomb news release. The laser features a curved interface designed to reduce the amount of corneal applanation and distortion, and real-time optical coherence tomography (OCT).
“The anterior segment OCT is really key to doing femtosecond laser surgery. It allows you to be sure that you’re doing your cutting exactly where you want,” Calvin W. Roberts, MD, chief medical officer at Bausch + Lomb, said in an interview with EyewireTV. “When you have a static picture, all you know is what everything looked like before you started, but with real-time OCT, what that allows you to do is follow the patient, and make sure that your applications are in exactly the right place, even should there be some movement of the eye during the procedure.”
The Victus platform received CE mark approval in Europe in November of 2011 for the creation of the LASIK flap, to perform astigmatic keratotomy, Intracor, capsulotomy, and lens fragmentation. It has been used in more than 2,000 cataract or refractive procedures around the world, according to Bausch + Lomb.
The two organizations are working to gain approval for additional applications in the United States.
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