FDA Approves New Bausch & Lomb Eye Surgery Device For U.S. Sale.
ROCHESTER, N.Y.--(BUSINESS WIRE)--Oct. 29, 2001
-- Innovative Technology Is Breakthrough for Vitreoretinal Microsurgery -- 25-Gauge Entry Site Alignment (ESA) Device Allows For Smaller Incisions
The U.S. Food and Drug Administration has cleared Bausch & Lomb's 510(k) application allowing the company to sell its innovative 25-Gauge Entry Site Alignment (ESA) device in the United States.
A patent is pending on this key component of the Bausch & Lomb Millennium(TM) TSV25 System for Transconjunctival Standard Vitrectomy, which is expected to be available starting in December.
The Bausch & Lomb system represents a technology breakthrough in surgery involving the back - or posterior segment - of the eye. The surgical technique, called vitrectomy, is used to correct visually devastating conditions including retinal detachments, macular degeneration, and diabetic eye diseases. Each year, surgeons perform an estimated 200,000 vitrectomies in the United States, and about 500,000 worldwide.
With Bausch & Lomb's Millennium TSV25 System, surgeons can make micro incisions that are approximately one half the size of standard incisions. The result is less trauma to the eye. The Bausch & Lomb Millennium TSV25 System is the only system this size available on the market.
Eugene de Juan, Jr., M.D., CEO of The Retina Institute at the Doheny Eye Institute of the University of Southern California at Los Angeles, says, "The 25-Gauge Entry Site Alignment and vitrectomy system, when used transconjunctivally, greatly facilitates the ease and speed of common vitreoretinal procedures. I expect this system to be quickly and widely used as part of our vitreoretinal armamentarium."
The Bausch & Lomb Millennium TSV25 System "moves us one step closer to performing micro surgery in office-based clinical settings," according to John Saharek, Bausch & Lomb marketing director for vitreoretinal products. "We see trends that these types of surgical procedures will be moving away from hospitals to office-based surgical suites. Doing so may lead to increased patient acceptance, convenience and access to care and also help to lower the overhead and personnel costs associated with these procedures."
Bausch & Lomb Incorporated is the preeminent global technology-based healthcare company for the eye, dedicated to helping consumers see, look and feel better through innovative technology and design. Its core businesses include soft and rigid gas permeable contact lenses, lens care products, ophthalmic surgical and pharmaceutical products. The company is advantaged with some of the most respected brands in the world starting with its name, Bausch & Lomb(R), and including SofLens(TM), PureVision(TM), Boston(R), ReNu(R), Storz(R) and Technolas(TM). Founded in 1853 in Rochester, N.Y., where it continues to have its headquarters, the company has annual revenues of approximately $1.8 billion and employs approximately 12,000 people in more than 50 countries. Bausch & Lomb products are available in more than 100 countries around the world. Additional information about the company can be found on Bausch & Lomb's Worldwide Web site at http://www.bausch.com.