Medical Device Daily
Carl Zeiss Meditec (Dublin, California) reported it has received FDA clearance to market the laser keratome applications of its Visumax femtosecond laser system and that it received the clearance sooner than expected. The company had projected the clearance would be granted in the second half of this year.
The Visumax system is designed to provide smooth and precise flap cutting capabilities for refractive laser surgery. A femtosecond is an interim of a quadrillionth of a second (Medical Device Daily, Jan. 9, 2007).
Carl Zeiss said the technology, combined with its MEL 80 excimer laser, delivers “excellent clinical outcomes” coupled with the potential for a “unique optimized workflow for refractive surgeons and improved comfort for their patients.”
Using a pivoting patient bed and an integrated data management system, the refractive surgeon will be able to complete a full refractive procedure without the need to move the patient or to perform redundant data entries, Zeiss said. Alternatively, either platform may be used separately and/or in conjunction with other laser systems, but without the full system integration benefits.
Jim Taylor, president/CEO of Carl Zeiss Meditec, told Medical Device Daily that commercial launch of the femtosecond technology is planned for later this year.
“We’re going to continue to do clinical work to further develop and demonstrate the capabilities [of the Visumax system], both as a laser keratome and as a patient management application, and we’re now putting together the global market and business platform for the combined solution,” Taylor told MDD.
Both MEL 80 and Visumax technologies were recently displayed and demonstrated at the annual meeting of the American Academy of Ophthalmology (AAO; San Francisco) in Las Vegas.
The MEL 80 is an advanced refractive laser system that has been marketed outside the U.S. since 2002 and recently gained FDA clearance for sale in the U.S. The company reported that the related clinical trials showed that 93% of patients were corrected to 20/20 or better visual acuity, with 41% achieving 20/12.5 or better at six months (MDD, Aug. 28, Nov. 16, 2006).
With the subsequent FDA clearance of the Visumax femtosecond platform, the company said it is now positioned to more fully exploit the technology advantages and clinical benefits of its full refractive laser portfolio.
“We believe that the field of refractive laser surgery offers significant opportunity for the type of technology innovation that Zeiss has pursued throughout our 160-year history,” Taylor said. “Since our initial disclosure of the clinical progress of our femtosecond system, we have been gratified by the enthusiastic encouragement and support that we have received from experienced refractive surgeons around the world. They recognize the inherent potentials in these advances along with the significant benefits that will emerge for patients and for clinicians who expect and require the most advanced refractive correction technologies and techniques.”
“The apparent advantages of the Visumax system are not limited to those normally recognized for a femtosecond laser flap cut,” said Walter Sekundo, MD, of the University of Mainz (Mainz, Germany). “Due to the special design of the contact glass and the low IOP increase, the perfusion of the central retinal artery has not been impaired, and our patients were able to see the fixation light throughout the procedure.
“Moreover, the Visumax provides a new level of cutting accuracy for corneal incisions, as evidenced by the results of our successful demonstration of the so-called Femtosecond Lenticule Extraction procedures.”
“In my opinion,” Sekundo said, “these features contributed significantly to our excellent visual acuity results of up to 20/10 one day post-op, and we saw no incidence of transient light sensitivity syndrome [TLSS] or DLK in any of the study group patients.”
The company said it will demonstrate the MEL 80 and the Visumax systems at the meeting of the American Academy of Refractive and Cataract Surgery (ASCRS; Fairfax, Virginia) in San Diego, April 27-May 1, and at the meeting of the European Society of Refractive and Cataract Surgery (ESCRS; Dublin, Ireland) in Stockholm, Sweden, Sept 8-12.
Carl Zeiss Meditec develops eye care solutions to diagnose and treat the four main diseases of the eye: vision defects (refraction), cataracts, glaucoma and retinal disorder.
Other companies in this sector include IntraLase (Irvine, California) which reported filing a lawsuit against Carl Zeiss Meditec last November, alleging that Zeiss breached an intellectual property agreement by improperly using proprietary information on IntraLase which Zeiss wrongfully induced IntraLase to disclose (MDD, Nov. 10, 2006). The suit seeks damages for breach of contract and payment of all revenues and profits derived by Zeiss for the sale and use of its laser.
IntraLase makes what it calls an ultra-fast laser-based technology used to create a corneal flap prior to laser refractive surgery. At the time the lawsuit was filed, IntraLase was heavily promoting its new corneal procedure called the IntraLase-Enabled Keratoplasty (IEK) that it launched in September 2006.
IEK is the first blade-free laser approach used to incise corneal tissue, according to IntraLase. The technology is designed to enable surgeons to create precisely shaped incisions that join the cornea and the transplanted tissue together like puzzle pieces (MDD, Nov. 14, 2006).
Earlier this month another California company in the laser vision correction market, Advanced Medical Optics (AMO; Santa Ana, California) reported it is acquiring IntraLase for $808 million (MDD, Jan. 9, 2007), a deal expected to close in the second quarter of this year.
AMO’s wavefront-guided laser vision correction technology (LVC) has been said to dramatically improving the outcomes of LVC by eliminating laser-induced spherical aberrations in the patient’s vision (MDD, Nov. 14, 2006).