Bausch + Lomb Introduces New Software and Advanced OCT Imaging System for VICTUS® Femtosecond Laser Platform
Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced that its wholly owned subsidiary, Bausch + Lomb, has 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 for its VICTUS® Femtosecond Laser Platform that will provide surgeons with a new, redesigned interface. The intuitive interface is designed to allow faster, simpler customized treatment planning to help surgeons improve efficiency and patient-flow during surgical procedures.
"With the availability of the advanced OCT imaging and software enhancements, surgeons can monitor treatments in real-time and with exceptional clarity throughout entire procedures, providing even greater control and consistency to support outstanding surgical outcomes for their patients," said Dr. Ari Kellen, executive vice president and company group chairman. "These new advancements demonstrate Valeant's commitment to innovation in eye health. We want to deliver technologies that improve clinical practice and provide the best quality of vision to patients."
The Swept Source OCT imaging system boasts high resolution imaging of the entire procedure and can be used to drive incision depth and detail the architecture of arcuate incisions. Together, the new software and imaging system will deliver auto-recognition of key landmarks in the eye, including the pupil, anterior capsule and posterior capsule, along with the capsule tilt compensation to maximize lens fragmentation.
Additional features of the advanced Swept Source OCT and software include:
- Improved imaging speed and sensitivity compared to conventional time domain detection techniques with unprecedented responsive video frame rate.
- High contrast, exceptional detail and clarity allow OCT-guided adjustment for all phases of cataract and corneal procedures during docking through planning and non-stop throughout treatment.
- OCT-guided planning of up to two arcuate incisions independently configurable in diameter, depth, position and size with a magnified cross-sectional scan allowing depth adjustment of the incisions utilizing pachymetry.
- Improved docking via high-contrast, live streaming OCT.
"As a user of the VICTUS femtosecond laser platform, I'm very excited about the latest upgrades for this versatile platform", saysTerrence P. O'Brien, M.D., professor of Ophthalmology and Charlotte Breyer Rodgers distinguished chair at the Bascom Palmer Eye Institute, University of Miami Miller School of Medicine. "The advanced higher resolution imaging system and faster, more intuitive software will allow cataract surgeons to be more efficient, accurate and precise than ever before. It has been gratifying to collaborate with the innovative team from Valeant and Bausch + Lomb to help develop and deliver crucial technological enhancements to better assist cataract surgeons in providing excellent visual outcomes for their patients."
Bausch + Lomb has been installing VICTUS platforms in leading surgery centers globally since it received CE mark in November 2011and the FDA clearances in July 2012. It is now 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.* The VICTUS platform has received additional CE marks including corneal incisions, penetrating keratoplasty and the creation of intrastromal channel incisions for intracorneal ring segments.
To learn more about 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.
About Valeant Pharmaceuticals International, Inc.
Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, eye health, neurology and branded generics. More information about Valeant Pharmaceuticals International, Inc. can be found at www.valeant.com.
About Bausch + Lomb
Bausch + Lomb, a Valeant Pharmaceuticals International, Inc. company, is a leading global eye health organization that is solely focused on protecting, enhancing, and restoring people's eyesight. Our core businesses include ophthalmic pharmaceuticals, contact lenses, lens care products, ophthalmic surgical devices and instruments. We develop, manufacture and market one of the most comprehensive product portfolios in our industry with products available in more than 100 countries.
*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.
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© 2014 Bausch & Lomb Incorporated.
This press release may contain forward-looking statements, including, but not limited to, statements regarding the future investment in R&D programs and the related benefits and effects of such programs. Forward-looking statements may be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the company's most recent annual or quarterly report filed with the Securities and Exchange Commission ("SEC") and other risks and uncertainties detailed from time to time in the Company's filings with the SEC and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.