510(k) For VICTUS™ Femtosecond Laser Platform

In short

Eye health company Bausch + Lomb, and Technolas ™ Perfect Vision GmbH (TPV™ ), a leading ophthalmology laser company, have jointly announced that the VICTUS™  Femtosecond Laser Platform has received FDA 510(k) clearance. The VICTUS platform is the first femtosecond laser capable of supporting cataract and corneal procedures on a single platform.

Background

While traditional cataract surgery is an established and successful technique, early published data suggest that Laser Refractive Cataract Surgery (LRCS), as offered by the VICTUS platform, may allow physicians to create a more precise, controllable and centred capsulotomy. Femtosecond lasers emit optical pulses of extremely short duration in the domain of “femtoseconds”, as short as one-quadrillionth of a second. These ultra-short pulses do not transfer heat or shock to the material being cut and can make surgical incisions with extreme precision.

Further clinical evidence exists suggesting that LRCS may require less phaco energy and time during lens fragmentation, improve intraocular lens placement, and potentially enhance patient outcomes and experience.1-3

We first reported on VICTUS last December, here, when the system gained CE mark approval, since when the company tells us it has been used on over 2000 cataract or refractive procedures around the world. Bausch + Lomb and TPV promote the VICTUS platform globally, leveraging their combined cataract and refractive expertise and commercial capabilities. Following this FDA clearance the two companies plan to immediately introduce and begin placing the VICTUS platform at leading surgery centers in the U.S.

Indications 

The VICTUS 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.

Clinician comments

“The introduction of femtosecond laser technology is the most significant advancement in cataract surgery in recent history,” said Steven J. Dell, M.D. of Dell Laser Consultants in Austin, Texas. “Cataract surgery, in its traditional form, delivers excellent results, and is arguably one of the safest and most successful surgical procedures performed anywhere in the body. The opportunity to further improve the outcomes of cataract surgery is something I am proud to be a part of. With its U.S. clearance, the VICTUS platform will offer unique advantages for both cataract and corneal procedures to surgeons and patients.”

Company comments

“The VICTUS platform represents a major advancement for ophthalmic surgeons that can potentially enhance patient outcomes,” said Kristian Hohla, Ph.D., chief executive officer of Technolas Perfect Vision. “We are committed to playing a leadership role in advancing femtosecond laser technology by working with customers, ophthalmic industry leaders and professional societies, alike. We look forward to the continued commercialization of the technology around the world, so that ophthalmic surgeons can experience its potential for themselves.”

“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 for Bausch + Lomb. “Since signing a definitive agreement with an option to purchase TPV last September, the two organizations have made substantial technical and commercial progress in the field of advanced refractive and cataract technologies. 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.”

References

1. Nagy Z, et al. Comparative analysis of femtolaser-assisted and manual capsularhexis during phacoemulsification. Presented at: XXVIII Congress of the European Society of Cataract and Refractive Surgeons; September 5, 2010; Paris, France.

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

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

Source: Bausch & Lomb Inc., PR Newswire