Tuesday, December 24, 2024

Bausch + Lomb Receives FDA Approval for TENEO™ Excimer Laser Platform for Myopia and Myopic Astigmatism LASIK Vision Correction Surgery

Bausch + Lomb Corporation, a leading global eye health company dedicated to helping people see better to live better, announced the U.S. Food and Drug Administration (FDA) has approved the TENEO Excimer Laser Platform for laser-assisted in situ keratomileusis (LASIK) vision correction surgery for myopia and myopic astigmatism (nearsightedness and nearsightedness with astigmatism)*.

“TENEO has been well received and is widely adopted in more than 50 countries around the world, and now U.S. ophthalmologists will benefit from this versatile laser,” said Luc Bonnefoy, president, Global Surgical, Bausch + Lomb. “The precise engineering of this platform delivers a fast, small, technologically advanced machine that provides an exceptional experience for both surgeons and patients.”

TENEO offers several unique features not offered by previous excimer laser platforms.

Accuracy

The advanced eye-tracker operates at 1,740Hz, which is more than three times the speed of the laser’s repetition. This feature helps to ensure the laser ablation pattern is not negatively impacted by a patient’s eye movement and helps achieve outstanding post-operative outcomes.

The platform’s high-speed laser operates at 500Hz, the fastest ablation time of all excimer lasers available in the United States at approximately 1.2 seconds per diopter.

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Efficiency

The platform’s customizable graphical user interface touchscreen simplifies set up and allows surgeons to access to the patient data they choose without flipping through screens.

The cutting edge TENEO software treats the manifest refraction and does not require a nomogram therefore streamlining surgical planning by eliminating several steps prior to treatment. The logical, intuitive process requires three steps: select patient; choose and confirm treatment; treat.

In addition to these time saving advantages, the compact design of the TENEO (0.6m(6.8 sq. ft)) makes it the smallest excimer laser unit available in the United States, freeing up limited clinical space, which is a critical concern for many surgeons.

Usability

TENEO has been specifically engineered for the comfort of both surgeons and patients. It features a 360o swivelling microscope that adapts to surgeon height and posture, aiding in surgeon comfort.

The treatment bed comfortably accommodates patients of all sizes, swings out for easier access, and can be customized for optimal head positioning. The bed can be swivelled to be positioned for a second treatment device† so that patients do not have to get up and move, enhancing comfort and simplifying the surgical process.

“FDA approval of TENEO represents a major milestone for the advancement of laser vision correction technology in the United States,” said George Waring IV, M.D., ophthalmologist and founder and medical director, Waring Vision Institute, Mt. Pleasant, S.C. “In addition to the technological advantages TENEO offers, the open air feeling around the laser and quiet performance contribute to a comfortable experience for the patient.”

SOURCE : BusinessWire

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