The US Food and Drug Administration (FDA) has granted 510(k) clearance to Bausch + Lomb and Technolas Perfect Vision’s Victus Femtosecond Laser platform for use during cataract and corneal surgical procedures.
The CE-marked Victus platform is designed to create a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea and anterior capsulotomy during cataract surgery.
Early published data suggest that laser refractive cataract surgery, as provided by the Victus platform, may allow physicians to create a controllable and centered capsulotomy, according to the company.
Technolas Perfect Vision (TPV) chief executive officer Kristian Hohla said the use of Victus platform helps ophthalmic surgeons to potentially enhance patient outcomes.
"We look forward to the continued commercialisation of the technology around the world, so that ophthalmic surgeons can experience its potential for themselves," Hohla added.
Bausch + Lomb global surgical business executive vice president and president John Barr said the company’s research and development partnership with TPV has allowed it to provide a broader suite of ophthalmic surgical products and expand the global reach of the new technology.
"Since signing a definitive agreement with an option to purchase TPV last September, the two organisations have made substantial technical and commercial progress in the field of advanced refractive and cataract technologies," Barr added.
"This FDA clearance further strengthens our relationship with TPV and we look forward to bringing the power of the Victus femtosecond laser to the U.S."
With plans to introduce the Victus platform at surgery centres in the US, both companies are working together to gain approval for additional US applications to maximise use of all of the capabilities of the Victus laser in cataract and refractive procedures.
Image: Bausch + Lomb’s headquarters in Rochester, New York, US. Photo: DanielPenfield.