Benefits to Patients and Practices Seen with the Femtosecond
Laser System Designed for Cataract and Corneal Surgery
ALISO VIEJO, CA & MUNICH, GERMANY — Bausch + Lomb, the global eye health company, and Technolas™ Perfect Vision GmbH (TPV), a leading ophthalmology laser company, announced today that high-volume cataract and refractive surgeons who have begun to use the VICTUS™ Femtosecond Laser Platform are already giving it high marks for design and performance.
The companies have been installing the VICTUS system in leading surgery centers around the country since it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in July for the 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, permitting cataract and corneal procedures on a single platform.
“We have entered a new era in laser vision correction and refractive cataract surgery,” said Steven J. Dell, M.D. of Dell Laser Consultants in Austin, Texas. "The VICTUS Platform integrates much of what the field has learned in the first few years of femto-assisted surgery, as well as in over two decades of ophthalmic laser development, providing technological and performance enhancements to the laser, procedural planning and monitoring capabilities, and the patient interface. This makes the VICTUS platform a welcome and useful addition to the successful anterior segment practice. I first performed femto-assisted surgery in 2010 with a prior platform, but the VICTUS incorporates a variety of technological improvements that have yielded excellent clinical results in my hands. I am very impressed by the quality of the capsulotomies, and I look forward to fully integrating all the capabilities of this revolutionary laser.”
While current cataract surgery techniques achieve positive outcomes, the procedure relies on multiple manual steps, which creates variability. Published data suggest that Laser Refractive Cataract Surgery (LRCS), as offered by the VICTUSplatform, 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).1,2,4,5 LRCS may require less phaco energy and time during lens fragmentation, improve intraocular lens placement, and potentially enhance patient outcomes and experience.1,3
"The VICTUS has performed very well 'out of the box' and we have already completed dozens of procedures using this versatile system," said Michael J. Endl, M.D., partner at Fichte Endl & Elmer Eyecare in Niagara Falls, New York. "The ability to create a perfectly consistent capsulotomy every time removes one of the rate-limiting steps in cataract surgery and helps make lens fixation more predictable. In LASIK surgery, the flap we create with the VICTUS leaves a beautiful stromal bed that supports excellent post-op results."
Among the other ophthalmic surgeons already installing the VICTUS platform are Harvey Carter, M.D., founder of Carter Eye Center, and Jeffrey Whitman, M.D., chief surgeon at Key-Whitman Eye Center, both in Dallas, Texas.
Robert J. Weinstock, M.D., FACS, director of cataract and refractive surgery at the Eye Institute of West Florida, has been using his VICTUS in both cataract and LASIK procedures for the past month. "I have performed more than 50 capsulotomies with VICTUS and have been impressed with how well the laser performs and integrates into the cataract surgery routine," said Dr. Weinstock. "The docking is quick and comfortable for the patient, the laser programming is seamless, and the treatment lasts just a few seconds. The capsulotomies are complete and free-floating, with very smooth edges and no residual tags or irregularities. We have also completed about a dozen LASIK flaps, all of which were performed quickly and were easy to lift. These patients were all 20/20 or better at their day one post-op visit. Given this positive initial experience, we eagerly await the clearance of additional modalities for the VICTUS platform."
Bausch + Lomb and Technolas Perfect Vision have been co-promoting the VICTUS platform globally, leveraging their combined cataract and refractive expertise and commercial capabilities. On Wednesday, Nov. 7, Bausch + Lomb announced that it exercised its option to purchase all outstanding and unowned shares of Technolas Perfect Vision, with the deal expected to close at the end of January 2013.
The VICTUS platform is cleared 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 product is now available for shipment in the U.S. The VICTUS platform received CE mark approval in Europe in November 2011 and has now been used in nearly 5,000 cataract or refractive procedures around the world. The two organizations are working to gain approval for additional applications in the U.S. to maximize use of all of the capabilities of the VICTUS laser in cataract and refractive procedures.
About Cataract Surgery
A cataract is a clouding of the normally clear lens in the eye. An estimated 20 million aging American baby boomers and seniors have cataracts. Each year, approximately 1.5 million people will have cataract surgery in the United States, making it one of the most common surgical procedures. According to the National Eye Institute, it is also one of the safest and most effective. 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 Technolas Perfect Vision
Technolas Perfect Vision GmbH (TPV) is a leading ophthalmology laser company, formed through a joint venture between Bausch + Lomb, and 20/10 Perfect Vision AG. TPV has a full range of expertise in both femtosecond and excimer businesses. Current innovations focus on laser cataract surgery and the correction of presbyopia with the SUPRACOR™ laser treatment. More information is available at www.technolaspv.com and www.better-reading-vision.net.
About Bausch + Lomb
Bausch + Lomb is one of the best-known and most respected healthcare companies in the world. Its core businesses include contact lenses and lens care products, ophthalmic surgical devices and instruments, and ophthalmic pharmaceuticals. Founded in 1853, the company is headquartered in Rochester, N.Y., and employs roughly 11,000 people worldwide. Its products are available in more than 100 countries. More information is available at www.bausch.com.
REFERENCES
1. 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.
2. Reddy K.P. Evaluation of the Precision and Predictability of Anterior Capsulotomy using a Femtosecond Laser. Presented at the annual meeting of the American Academy of Ophthalmology in Orlando, Florida; October 22 - 25, 2011.
3. 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.
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. Reddy, K.P. Investigation into the precision and accuracy of femtosecond laser cataract surgery. Presented at the annual meeting of the ESCRS in Milan, Italy, 2012.
VICTUS™ is a trademark of Bausch & Lomb Incorporated or its affiliates.
TECHNOLAS™ and SUPRACOR™ are trademarks of Technolas™ Perfect Vision GmbH.
© 2012 Bausch & Lomb Incorporated.
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News Media Contacts:
Jeanie Herbert
Global Surgical Communications, Bausch + Lomb
(949) 521-7948, (714) 325-3584 (mobile) or jeanie.herbert@bausch.com
Elizabeth Murphy
Global Communications, Bausch + Lomb
(585) 338-8528 or elizabeth.murphy@bausch.com
Tad Heitmann
BioComm Network on behalf of Bausch + Lomb
(714) 273-2937 or theitmann@BioCommNetwork.com
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