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 1. (architecture) ESA - Enterprise Systems Architecture.
2. (body) ESA - European Space Agency. ) device in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. .
A patent is pending on this key component of the Bausch & Lomb Millennium(TM) TSV TSV - tab-separated values 25 System for Transconjunctival Standard Vitrectomy Vitrectomy Definition
Vitrectomy is the surgical removal of the vitreous (transparent gel that fills the eye from the iris to the retina).
Purpose , 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 dev·as·tate
tr.v. dev·as·tat·ed, dev·as·tat·ing, dev·as·tates
1. To lay waste; destroy.
2. To overwhelm; confound; stun: was devastated by the rude remark. conditions including retinal detachments, macular degeneration macular degeneration, eye disorder causing loss of central vision. The affected area, the macula, lies at the back of the retina and is the part that produces the sharpest vision. , 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of The Retina Institute at the Doheny Eye Institute of the University of Southern California The U.S. News & World Report ranked USC 27th among all universities in the United States in its 2008 ranking of "America's Best Colleges", also designating it as one of the "most selective universities" for admitting 8,634 of the almost 34,000 who applied for freshman admission 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 ar·ma·men·tar·i·um
n. pl. ar·ma·men·tar·i·ums or ar·ma·men·tar·i·a
The complete equipment of a physician or medical institution, including drugs, books, supplies, and instruments. ."
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.