Femtosecond laser cleared by FDA

Aliso Viejo, CA, and Munich, Germany-Bausch + Lomb (B + L) and Technolas Perfect Vision GmbH (TPV) have received 510(k) clearance from the FDA for a femtosecond laser platform (Victus), and it is now available for shipment within the United States.

Specifically, the platform has been cleared for the 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. The companies plan to seek FDA clearance for additional indications.

According to the two companies, the technology is the first femtosecond laser capable of supporting cataract and corneal procedures on a single platform. “The . . . platform represents a major advancement for ophthalmic surgeons that can potentially enhance patient outcomes," said Kristian Hohla, PhD, chief executive officer, TPV.

The platform is designed to reduce the number of steps and variability involved with cataract surgery. Early published data, according to the companies, suggest that cataract surgery performed using the new technology may allow physicians to create a more precise, controllable, and centered capsulotomy. The procedure, they add, may require less phacoemulsification energy and time during lens fragmentation, improve IOL placement, and potentially enhance patient outcomes and experience.

The system received CE mark approval in Europe in November and has been used in more than 2,000 cataract or refractive procedures around the world, according to B + L and TPV, which are working together to promote the technology around the world. Under terms of an agreement signed in September, B + L has an option to purchase TPV.

“Our pioneering research and development partnership with TPV has delivered innovation in laser surgery that allows us to offer a broader suite of ophthalmic surgical products and expand the global reach of this exciting new technology,” said John Barr, executive vice president and president, global surgical business, B + L. The FDA clearance, he added, “further strengthens our relationship with TPV.”

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