LenSx (Aliso Viejo, California) made huge gains in the race for the broad commercialization of treating cataract patients with an “all laser“ procedure. The company reported that the first patient cases were treated in the U.S. using its femtosecond laser.

LenSx is in a tight race with LensAR (Winter Park, Florida) and OptiMedica (Santa Clara, California) to bring a fully commercialized product to what some call a “fledgling“ sector.

“In my mind, [the femtosecond laser] is the hot topic in ophthalmic surgery this year,“ Larry Haimovitch, president of HaimovitchMedical Technology Consultants (Mill Valley, California) and a regular contributor to Medical Device Daily.

The procedure differs from past methods. Typically previous techniques involving the cataracts were manual and required several steps. The surgical skill to do a “perfect“ removal of the cataract is considerable and the procedure is fraught with risks. These adverse events include posterior capsule rupture, the loss of endothelial cells, macular edema, retinal detachment, compromised zonules (ligaments that hold the lens in place) and perhaps most serious of all endophthalmitis.

But this new approach is said to remove some of those risks and converts the various steps in today's cataract removal procedure into one that utilizes laser-created, surgeon-controlled precision. The school of thought is that laser-accuracy will greatly enhance the results that are achieved by the surgeon's hands.

LenSx in particular reported that Stephen Slade, MD, of Slade & Baker Vision (Houston), performed the first cases with the LenSx laser. According to the company, Slade performed the surgeries with the system in his office-based ambulatory surgery center in Houston.

LenSx received an initial femtosecond laser clearance for a cataract surgery indication in August 2009 for anterior capsulotomy followed by a clearance for corneal incisions in December 2009.

In findings presented at last year's American Society of Cataract and Refractive Surgery (ASCRS; Reston, Virginia) it was shown that LenSx system was extremely accurate for capsulotomy diameter, with 100% achieving the desired diameter. Conversely, manually performed procedures attained an accuracy of +/-0.25 millimeters in only 20% of the time. It was also pointed out that the LenSx system required less power and effective time to complete the procedure.

One of the huge benefits of this new technology is that it will provide a better capsulotomy prior to implantation of a “premium“ intraocular lens (IOL). Premium IOLs encompass both multi-focals and accommodating IOLs and enable most patients to either reduce or eliminate their need for reading glasses after cataract surgery. They are significantly premium-priced compared to standard monofocal IOLs and therefore patient expectations of an excellent outcome are far higher.

But several questions of the technology still remain, including who will bring the technology to the market first.

In an interview with Medical Device Daily late last year, LensAR's CEO, Randy Frey said that it is in a head-to-head competition to be the first to commercialize the laser technology (MDD, Nov. 6, 2009). However, Frey claims that he holds important patent applications, which allow the company to focus on R&D and pay less attention to competitors. He said he believes that LensAR's patents will prevail and will have a legal claim on any such devices, regardless of their maker.

Another question remains on how the technology, which is said to be very expensive, will be used in a time of shrinking reimbursements and stringent health insurance policies.

“Here's the challenge of this technology,“ Haimovitch said. “It will be very expensive and the doctors are not going to get any extra reimbursement for it, but will the doctor be able to get more out of pocket from the patient for the procedure? Can the doctor say, yes I can do this procedure manually, but if I can do it better with just using the laser would it be worth it to the patient to pay [out of pocket] for each eye? That's the biggest question right now. How is the business model for this procedure going to look?“

The first ophthalmic femtosecond lasers were introduced as alternatives to automated mechanical blades used in LASIK. Since 2001, more than three million femtosecond laser procedures have been performed, offering refractive surgery patients enhanced precision and safety.

Omar Ford, 404-262-5546;
omar.ford@ahcmedia.com