Bausch + Lomb's Femtosecond Laser Platform Receives 510(k) Clearance from FDA for Lens Fragmentation Procedure
Valeant Pharmaceuticals International, Inc. has announced that its wholly owned subsidiary, Bausch + Lomb has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VICTUS Femtosecond Laser Platform for laser-assisted lens fragmentation during cataract surgery.
The fragmentation procedure, which follows a capsulotomy, uses the femtosecond laser to split the cataractous lens into sections. This is followed by phacoemulsification for cataract removal. The VICTUS platform offers a number of different lens fragmentation patterns depending on the cataract grade and user preference.
"Valeant is committed to innovation in healthcare and continues to fund important R&D programs that will bring benefits to physicians and the patients they serve," stated J. Michael Pearson, chairman and chief executive officer, Valeant Pharmaceuticals International, Inc. "We will continue to invest in important advancements that will broaden our eye health product offerings and further enhance the strength of the Bausch + Lomb brand."
"Academic research has shown that cataracts pre-treated with lens fragmentation can require less phacoemulsification energy for removal," said Y. Ralph Chu, M.D., founder and director of the Chu Vision Institute, Bloomington, MN. "In lower grade cataracts, we have seen up to a 50 percent reduction in the phaco energy required to remove the lens following lens fragmentation with the laser, compared with standard phaco."
Bausch + Lomb has been installing VICTUS platforms in leading surgery centers globally since it received CE mark in November 2011 and the FDA clearances in July 2012. It is now one of the only femtosecond lasers in the U.S. with clearance for the creation of a corneal flap in patients undergoing LASIK surgery, anterior capsulotomy during cataract surgery, penetrating arcuate cuts/incisions in the cornea and laser-assisted lens fragmentation during cataract surgery. The VICTUS platform has received additional CE marks for the following, which include: INTRACOR® treatment used for flapless intrastromal correction, corneal incisions, penetrating keratoplasty and the creation of intrastromal channel incisions for intracorneal ring segments.
"The VICTUS femtosecond laser platform delivers major advancements in cataract and refractive surgery, with a combination of precision and simplification for several of the key procedures," said Dr. Chu. "Laser-assisted capsulotomies and fragmentation may improve the consistency and precision of cataract procedures and will contribute to our ability to provide excellent post-surgical outcomes."
"Bausch + Lomb has made great progress building out a comprehensive and competitive product portfolio for ophthalmic surgeons, and today's lens fragmentation clearance on the VICTUS platform further strengthens our offerings," said Calvin Roberts, M.D., chief medical officer, Bausch + Lomb. "For cataract, refractive or retinal surgery, the more you look at Bausch + Lomb, the more you'll see that we have the platforms, intraocular lenses, instruments, packs, and distribution partnerships that together are helping improve patients' vision and eye health."