8/3/2015, Monday

Bausch + Lomb’s VICTUS® Femtosecond Laser Platform Receives 510(k) Clearance from FDA for Enhanced Patient Interface Kit

New System Features Enhanced Design, Ergonomics and Broader Range of Patient Inclusion

FOR RELEASE MONDAY, AUGUST 3, 2015

BRIDGEWATER, NJ — Bausch + Lomb, a leading global eye health company, announced today its VICTUS® Femtosecond Laser Platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an enhanced patient interface kit. The interface features a smaller diameter suction clip, which has been modified to allow for easier opening and closing of the clip, based on customer feedback, to help facilitate more efficient placement of the clip in patients with narrow fissures and smaller eye openings.

“We are very pleased to provide this advancement to our VICTUS Femtosecond Laser to surgeons and their patients,” said Dr. Ari Kellen, Head of U.S. Eye Health, Bausch + Lomb. “Bausch + Lomb takes pride in the close partnership we have with surgeons, and doctors are often the best source of innovation. We are committed to investing in the technology and surgical enhancements to meet the needs of doctors and their patients. This clearance further exemplifies Bausch + Lomb’s leadership in femtosecond technology.”

Additional features of the enhanced patient interface kit, which is intended to enhance the performance of the suction ring as well as laser operation function, include:

Colored Suction Skirt: The colored skirt of the suction clip will help assist surgeons in achieving optimal centration to avoid the introduction of tilt as well as to optimize the inner working diameter of the suction ring. Eliminating such tilt will also help surgeons ensure that corneal incisions and arcuate incisions are placed accurately on the cornea.
Multi-port Suction Design: Multiple suction ports along the inside of the ring were incorporated to assist surgeons in obtaining optimal control of the eye throughout the VICTUS Femtosecond laser procedure. The multi-port suction is designed to provide enhanced stability on the eye during laser planning and treatment while distributing the vacuum level throughout multiple ports to improve patient comfort during the procedure.
Ergonomical Design: An enhanced contoured handle allows surgeons comfortable grip and improved control of the suction clip, including an easy lock/unlock feature.

“The smaller profile in the enhanced patient interface kit for the VICTUS Femtosecond Laser Platform will allow surgeons to have even greater control and ease of use in patients with narrow fissures further supporting improved suction and better overall comfort,” said Jeffrey Whitman, M.D., president and chief surgeon at the Key-Whitman Eye Center in Dallas, TX. “I also look forward to utilizing the colored suction skirt to help facilitate centering on the cornea of the eye and multi-port suction design to ensure stability of the globe throughout the entire procedure.”

The VICTUS Femtosecond Laser Platform is one of the only femtosecond lasers in the U.S. with clearance 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.*

Earlier this year, the VICTUS Femtosecond Laser Platform received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an advanced Swept Source OCT (Optical Coherence Tomography) imaging system and updated software that allows customized treatment planning for improved efficiency and patient-flow during surgical procedures. VICTUS platform has additional CE marks including corneal incisions, penetrating keratoplasty and the creation of intrastromal channel incisions for intracorneal ring segments.

For more information on the VICTUS Femtosecond Laser Platform, visit: http://www.victuslaser.com/ .

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.

*The VICTUS Femtosecond Laser Platform is indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; for anterior capsulotomy during cataract surgery; and for the creation of cuts/incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring cuts/incisions in the cornea and for laser assisted fragmentation during cataract surgery for nuclear cataracts, not for fragmentation of posterior subcapsular and cortical cataracts.

VICTUS is a trademark of Bausch & Lomb Incorporated or its affiliates.
© 2015 Bausch & Lomb Incorporated.

News Media Contact
Kristy Marks
Manager, Product PR, Bausch + Lomb
(585) 338-8095 or kristy.marks@bausch.com

Teresa Panas
BioComm Network, on behalf of Bausch + Lomb
(973) 809-8590 or tpanas@biocommnetwork.com

Tad Heitmann
BioComm Network, on behalf of Bausch + Lomb
(714) 273-2937 or theitmann@BioCommNetwork.com
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