LAVAL, Quebec -- Valeant Pharmaceuticals International, Inc. announces 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 includes:
• 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", says Terrence 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 2011 and 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.