-Bausch + Lomb (B + L) and Technolas Perfect Vision GmbH (TPV) have received 510(k)  clearance from the FDA for a femtosecond laser platform (

), 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 

 surgery or other treatment requiring  initial lamellar resection of the cornea and anterior capsulotomy during  

. 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.”

News

Bausch + Lomb (B + L) and Technolas Perfect Vision GmbH (TPV) have received 510(k) clearance from the FDA for femtosecond laser platform, Victus.