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Femtosecond eye surgery system gets EU approval

07 Dec 2011

'VICTUS' platform, which performs both cataract and refractive procedures, set to ship by year-end.

A new femtosecond laser system that provides a single platform to perform a wide variety of surgical eye procedures has received CE mark approval for sale in the European Union, and will begin to ship before the end of the year.

Developed by eye care giant Bausch + Lomb in collaboration with its close associate Technolas Perfect Vision (TPV), the “VICTUS” platform is approved for various elements of cataract, refractive and therapeutic procedures. While the femtosecond laser provides higher precision than conventional approaches, with minimal heating of tissue, the versatility of VICTUS means that eye specialists should be able to incorporate it into their clinics more economically than with multiple systems.

Robert Grant, CEO of Bausch + Lomb’s global surgical business unit, described the latest approval as a major step for femtosecond lasers, by elevating the role that the technology can play in both refractive and cataract surgeries. The system is approved for LASIK flap, astigmatic keratotomy and INTRACOR (a presbyopia treatment) refractive procedures, as well as capsulotomy and lens fragmentation steps for cataract treatment.

TPV’s CEO Kristian Hohla said in a statement announcing the latest regulatory approval: “Our focus has been to empower ophthalmic surgeons with the latest advances in laser technology in order to provide patients with better outcomes and quality of life.”

Global impact
A platform capable of both cataract and refractive surgeries means a major step up in the potential market for the femtosecond laser technology. According to World Health Organization statistics, one-third of the 285 million people around the world that are said to be either visually impaired or blind are suffering from cataracts – with 43% affected by severe refractive defects of astigmatism, short- or long-sightedness.

Bausch + Lomb estimates that more than 15 million cataract surgeries, where a patient’s clouded natural lens is replaced with a transparent intraocular lens, are performed each year.

Initially formed as a joint venture between Bausch + Lomb and 20/10 Perfect Vision, TPV is now set to become a full subsidiary of Bausch + Lomb. In September the two companies agreed a deal valuing TPV at up to €450 million, depending on various milestones and earn-outs.

"The promise of femtosecond technology is why we are so excited to be bringing TPV back within our surgical ophthalmic portfolio," Robert Grant told optics.org at the time.

Bausch + Lomb will face some stiff competition in what is set to be a growing market as the global population ages, however. As well as rival laser systems for cataract applications from Alcon, LensAR and OptiMedica, US-based AcuFocus last week raised $65 million in venture finance to support its "KAMRA" implant treatment for presbyopia.

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