Health Canada MDL for VICTUS Laser Platform

Bausch + Lomb, the global eye health company, announced today that its VICTUS Femtosecond Laser Platform was issued a Health Canada Medical Device Licence (MDL). The VICTUS Femtosecond Laser Platform, capable of supporting cataract and corneal procedures on a single platform, offers greater consistency and precision over manual cataract surgery techniques.^1,2

The VICTUS platform is one of the only femtosecond lasers in Canada with a licence 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. Bausch + Lomb Technolas (Technolas Perfect Vision GmbH) has been installing VICTUS platforms in leading surgery centers globally since it received CE mark in November 2011 and U.S. FDA clearance in July 2012.

“The VICTUS platform delivers major advancements in cataract and refractive surgery, allowing ophthalmic surgeons to perform multiple bladeless, sight-enhancing procedures on a single system,” says Jonathan Abrams, commercial director for Bausch + Lomb Surgical, Canada. “We are committed to playing a leadership role in advancing femtosecond laser technology by working with ophthalmic industry leaders and professional societies alike. We look forward to introducing this technology in Canada, so that ophthalmic surgeons can experience its potential for themselves.”

While current cataract surgery techniques achieve positive outcomes, the procedure relies on multiple manual steps, which creates variability. Early published data suggest that laser refractive cataract surgery (LRCS), as offered by the VICTUS platform, may allow physicians to create a more precise, controllable and centered capsulotomy (an incision in the capsular bag that allows access to the cataract-clouded natural lens).^3,4 LRCS may also require less phaco energy and time during lens fragmentation, improve intraocular lens placement, and potentially enhance patient outcomes and experience.⁵

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 is a leading global eye health company 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. Founded in 1853, our company is headquartered in Rochester, NY, and employs more than 11,000 people worldwide.

REFERENCES
^{1. Reddy KP. Evaluation of the Precision and Predictability of Anterior Capsulotomy using a Femtosecond Laser. Presented at: The Annual Meeting of the American Academy of Ophthalmology (AAO); October 22 - 25, 2011; Orlando, Florida.}

^{2. Reddy KP. Investigation into the precision and accuracy of femtosecond laser cataract surgery. Presented at: The Annual Meeting of the European Society of Cataract and Refractive Surgeons (ESCRS); September 8-12, 2012; Milan, Italy.} 

^{3. Nagy Z, et al. Comparative analysis of femtolaser-assisted and manual capsularhexis during phacoemulsification. Presented at: XXVIII Congress of the European Society of Cataract and Refractive Surgeons; September 5, 2010; Paris, France.}

^{4. Batlle J, et al. Prospective randomized study of size and shape accuracy of OptiMedica femtosecond laser capsulotomy vs. manual capsularhexis. Presented at: XXVIII Congress of the European Society of Cataract and Refractive Surgeons; September 5, 2010; Paris, France.}

^{5. Koch D, et al. The use of OCT-guided femtosecond laser to facilitate cataract nuclear disassembly and aspiration. Presented at: XXVIII Congress of the European Society of Cataract and Refractive Surgeons; September 5, 2010; Paris, France.}