Bausch + Lomb, Technolas Perfect Vision gain FDA approval for femtosecond laser platform

Bausch + Lomb (Aliso Viejo, CA) and ophthalmology laser company Technolas Perfect Vision (TPV; Munich, Germany) have received FDA clearance for the VICTUS femtosecond laser platform, which supports cataract and corneal procedures on one system.

The two companies plan to introduce and begin placing the platform at leading surgery centers in the US. The platform received CE mark approval in Europe in November 2011 and has been used in more than 2,000 cataract or refractive procedures around the world. The two organizations are working towards approval for additional applications in the US to maximize use of all of the unique capabilities of the laser in cataract and refractive procedures.

While current cataract surgery techniques achieve positive outcomes, the procedure relies on multiple manual steps, which creates variability. Early published data suggest that laser refractive cataract surgery (LRCS) may allow physicians to create a more precise, controllable, and centered capsulotomy (an incision in the capsular bag that allows access to the cataract-clouded natural lens). LRCS may require less phaco energy and time during lens fragmentation, improve intraocular lens placement, and potentially enhance patient outcomes and experience.^1-3

The platform is cleared for creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea and anterior capsulotomy during cataract surgery, with plans to submit additional indications to the FDA. The product is now available for shipment in the US.

For more information, please visit http://www.technolaspv.com/procedures/femto-cataract/femto-cataract_100858_0.html.

REFERENCES
1. Z. Nagy et al., "Comparative analysis of femtolaser-assisted and manual capsularhexis during phacoemulsification," XXVIII Congress of the European Society of Cataract and Refractive Surgeons, Paris, France (September 5, 2010).

2. D. Koch et al., "The use of OCT-guided femtosecond laser to facilitate cataract nuclear disassembly and aspiration," XXVIII Congress of the European Society of Cataract and Refractive Surgeons, Paris, France (September 5, 2010).

3. J. Batlle et al., "Prospective randomized study of size and shape accuracy of OptiMedica femtosecond laser capsulotomy vs. manual capsularhexis," XXVIII Congress of the European Society of Cataract and Refractive Surgeons, Paris, France (September 5, 2010).
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