FDA grants 510(k) clearance to VICTUS Femtosecond Laser Platform

Bausch + Lomb, the global eye health company, and Technolas™ Perfect Vision GmbH (TPV), a leading ophthalmology laser company, announced today that the VICTUS™ Femtosecond Laser Platform received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The VICTUS platform is the first femtosecond laser capable of supporting cataract and corneal procedures on a single platform. The versatile system is designed to provide greater precision compared to manual cataract surgery techniques, potentially enhancing patient experience.

The two companies plan to immediately introduce and begin placing the VICTUS platform at leading surgery centers in the U.S. Together, Bausch + Lomb and TPV promote the VICTUS platform globally, leveraging their combined cataract and refractive expertise and commercial capabilities. The VICTUS platform received CE mark approval in Europe in November of 2011 and has been used in more than two thousand 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 unique capabilities of the VICTUS laser in cataract and refractive procedures. 

"The introduction of femtosecond laser technology is the most significant advancement in cataract surgery in recent history," said Steven J. Dell, M.D. of Dell Laser Consultants in Austin, Texas.  "Cataract surgery, in its traditional form, delivers excellent results, and is arguably one of the safest and most successful surgical procedures performed anywhere in the body. The opportunity to further improve the outcomes of cataract surgery is something I am proud to be a part of. With its U.S. clearance, the VICTUS platform will offer unique advantages for both cataract and corneal procedures to surgeons and patients."

"The VICTUS platform represents a major advancement for ophthalmic surgeons that can potentially enhance patient outcomes," said Kristian Hohla, Ph.D., chief executive officer of Technolas Perfect Vision. "We are committed to playing a leadership role in advancing femtosecond laser technology by working with customers, ophthalmic industry leaders and professional societies, alike. We look forward to the continued commercialization of the technology around the world, so that ophthalmic surgeons can experience its potential for themselves."

"Our pioneering research and development partnership with TPV has delivered innovation in laser surgery that allows us to offer a broader suite of ophthalmic surgical products and expand the global reach of this exciting new technology," said John Barr, executive vice president and president, global Surgical business for Bausch + Lomb. "Since signing a definitive agreement with an option to purchase TPV last September, the two organizations have made substantial technical and commercial progress in the field of advanced refractive and cataract technologies. This FDA clearance further strengthens our relationship with TPV and we look forward to bringing the power of the VICTUS femtosecond laser to the U.S."

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).  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 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, with plans to submit additional indications to the FDA. The product is now available for shipment in the U.S.