19 Jun 2012
Developer LensAR says that final preparations for a US launch are under way, following latest regulatory clearance.
Another femtosecond laser system for cataract surgery is about to launch in the US, following clearance from the Food & Drug Administration (FDA) for LensAR’s “next-generation” platform.
The latest FDA approval means that the LensAR Laser System can be used both with and without a laser phacofragmentation step during cataract surgery.
The venture-backed Florida firm, which raised $24 million earlier this year, says that its system has an advantage over those of its rivals resulting from precise three-dimensional imaging of a patient’s eye – accounting for individual anatomical quirks such as lens tilt and visual axis for a more “personalized” treatment.
In the new LensAR system, a rotating camera is used to generate a single, unstitched image of the eye and the lens within. That is said to provide a clean, low-noise and high-resolution view from the anterior surface of the cornea to the posterior capsule, enabling very precise incisions and fragmentation of high-grade cataracts for easier removal.
CEO Nick Curtis says that, following the latest FDA approval, the company is “one critical step closer” to commercializing its system in the US. At present, LensAR has one system deployed in the Philippines and a second in Peru, with around 30 surgeons said to have gained experience by conducting procedures.
“With final preparations for our US commercial launch under way, we are excited to begin working with cataract surgeons across the country to integrate our leading laser technology into their practices,” stated Curtis.
While femtosecond lasers have been used for several years in the field of elective refractive surgery, their emergence in cataract procedures – which, with an ageing population, presents a much larger market opportunity – has taken much longer.
However, LensAR will be up against some tough competition from other venture-backed rivals, as well as some much larger and world-leading medical device companies, as it strives to gain market share.
California-based OptiMedica, which has licensed pattern-scanning laser technology from Stanford University, gained FDA approval for its “Catalys” femtosecond laser system for cataract surgery in February this year, and has since gained CE mark approval in the European Union and moved to a much larger headquarters in anticipation of growing global demand. The OptiMedica system also uses optical coherence tomography imaging to improve positional accuracy.
Alcon-owned LenSx Lasers already has femtosecond systems for cataract treatment installed in the US, the UK, Europe and Australia, while Bausch & Lomb’s “Technolas Perfect Vision” subsidiary unveiled its “Victus” femtosecond platform last year.
LensAR is also working on a combined surgical treatment for both cataracts and presbyopia, the age-related hardening of the eye's lens that tends to affect vision in people from middle age onwards. The combined procedure is seen as an attractive option for older patients seeking a glasses-free retirement.