CE Mark Approval for Bausch & Lomb Victus Femtosecond Laser

First Single-Platform Femtosecond Laser Now Commercially Available in European Union

Abstract

Bausch + Lomb, the global leader in eye health, and Technolas™ Perfect Vision GmbH (TPV), a leading ophthalmology laser company, announced the commercial availability of the VICTUS™ Femtosecond Laser Platform in the European Union (EU). The VICTUS platform is CE mark approved for LASIK flap, astigmatic keratotomy, INTRACOR, capsulotomy and lens fragmentation and represents the first single-platform Femtosecond Laser to be commercially available in Europe.

“This is a significant milestone for Bausch + Lomb that will deliver breakthrough capabilities to our eye care professionals and the patients they serve”

Background

An estimated 285 million people are visually impaired worldwide and approximately 33 percent of visual impairments are due to cataracts. Over 15 million cataract surgeries are performed worldwide each year. Cataract surgery is a simple procedure during which the natural lens in the patient’s eye is surgically replaced with an intraocular lens. This new technology will enable clinicians to perform the procedure with greater precision than manual techniques allow.

Femtosecond Laser technology

Femtosecond lasers emit optical pulses of extremely short duration in the domain of femtoseconds, as short as one-quadrillionth of a second. With these ultra-short pulses, tissue can be cut more precisely and with practically no heat development. The femtosecond laser technology enables greater precision in both cataract and refractive procedures compared to manual techniques, giving ophthalmologists more control and potentially enhancing the patient experience.

The VICTUS platform is uniquely designed to support cataract, refractive and therapeutic procedures all on a single platform

Product Introduction

The VICTUS platform as well as early clinical data was presented at the 2011 European Society of Cataract and Refractive Surgeons (ESCRS) Congress in Vienna, the American Academy of Ophthalmology (AAO) Annual Meeting in Orlando and at the Asia-Pacific Association of Cataract and Refractive Surgeons (APACRS) in Seoul earlier this year. Plans to submit the data for publication in peer-reviewed journals are underway.

Bausch + Lomb and TPV will promote the VICTUS platform globally, leveraging their combined cataract and refractive expertise and commercial capabilities. The two organizations are also working with regulatory authorities around the world to secure additional marketing approvals for the platform.

Company comments

“This is a significant milestone for Bausch + Lomb that will deliver breakthrough capabilities to our eye care professionals and the patients they serve,” said Brent Saunders, chief executive officer of Bausch + Lomb.

“This CE mark approval represents a major step for femtosecond laser technology by elevating the role that laser technology can play in refractive and cataract procedures,” said Robert E. Grant, EVP and president and CEO, Global Surgical Business, for Bausch + Lomb. “I am excited that we will begin shipping product by the end of the year.”

“Our focus has been to empower ophthalmic surgeons with the latest advances in laser technology in order to potentially provide patients with better outcomes and quality of life,” said Kristian Hohla, PhD, chief executive officer of Technolas Perfect Vision. “We are very pleased that, together with Bausch + Lomb, we have demonstrated the viability of the VICTUS platform for enhanced cataract surgery.”

Source: Bausch and Lomb

 

 

published: December 7, 2011 in: Approval/Clearance, Launches / Withdrawals, Ophthalmics, Regulatory

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