BRIDGEWATER, N.J. – Bausch + Lomb, the leading global eye health company, today announced the VICTUS® Femtosecond Laser Platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the creation of cuts/incisions in the cornea of patients undergoing cataract surgery or other ophthalmic treatment requiring cuts/incisions in the cornea. Corneal incisions can now be made in a wide variety of diameters, depths, angles and planes. With the new indication, virtually blade-free cataract surgery is now possible using the VICTUS Platform.
“This additional indication for the VICTUS® Femtosecond Laser Platform will allow surgeons to have even greater control and precision in making corneal incisions during cataract procedures, further supporting outstanding outcomes for their patients,” said Y. Ralph Chu, M.D. “For their part, patients appreciate the fact that our incisions are made with ‘light’ and not with a ‘knife’ potentially removing one more source of anxiety for the cataract patient.”
In July 2012, VICTUS received 510(k) clearance in the U.S. 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. In February 2013, VICTUS received FDA clearance for arcuate incisions. In Europe, the VICTUS platform also has CE Marking for capsulotomy, lens fragmentation, arcuate corneal incisions, corneal incisions, LASIK flap, penetrating keratoplasty and intrastromal channel incisions for intracorneal ring segments.
The VICTUS Femtosecond Laser Platform is designed to support a comprehensive suite of cataract and corneal procedures in a single instrument. This new indication will function in concert with existing advanced proprietary features including an easy-to-use patient interface and real-time OCT imaging to optimize each cataract procedure being performed.
“As we continue to gain clearances for additional procedures, we approach the day when surgeons can harness the full, inherent functionality and versatility of the VICTUS Femtosecond Laser Platform for their cataract and refractive patients,” said Calvin Roberts, M.D., Chief Medical Officer, Bausch + Lomb. “This innovative system was conceived as the backbone of the successful ophthalmic practice today -- and tomorrow -- and it represents Bausch + Lomb’s unwavering commitment to offering the very finest in intraocular lenses, surgical instrumentation, and advanced procedures to our customers.”
To learn more about the VICTUS Femtosecond Laser Platform, please visit: http://www.victuslaser.com/.
About Cataract Surgery
According to the World Health Organization, there are about 100 million people in the world today who are 80 years old or older. That number is expected to almost quadruple by 2050. Aging is the leading cause of eye diseases, such as cataracts. A cataract is a clouding of the normally clear lens in the eye. It also happens to be the leading cause of blindness in the world. According to the U.S. National Eye Institute, cataract surgery is one of the safest, most common and effective surgical procedures. Worldwide, over 20 million cataract surgeries are performed annually. Cataract surgery is a simple procedure during which the natural lens in the patient's eye is surgically replaced with an intraocular lens (IOL).
About Femtosecond Lasers
Femtosecond lasers emit optical pulses of extremely short duration in the domain of femtoseconds, as short as one-quadrillionth of a second. These ultra-short pulses do not transfer heat or shock to the material being cut and can make surgical incisions with extreme precision. The technology was developed in the early 1990s at the University of Michigan Engineering Center. The first commercial platform was introduced in 2002 and the original approval was for flap creation during LASIK surgery. Recent platform approvals have been expanded to include additional corneal/therapeutic procedures and cataract applications.
About Bausch + Lomb
Bausch + Lomb, a Valeant Pharmaceuticals International, Inc. company, is a leading global eye health organization that is solely focused on protecting, enhancing, and restoring people’s eyesight. Our core businesses include ophthalmic pharmaceuticals, contact lenses and lens care products, and ophthalmic surgical devices and instruments. We globally develop, manufacture and market one of the most comprehensive product portfolios in our industry, which are available in more than 100 countries.