22 Dec 2011
Venture-backed US firm gets 510(k) approval for its femtosecond laser / optical coherence tomography combination system.
The California-based ophthalmology company OptiMedica has received 510(k) market clearance from the US Food and Drug Administration (FDA) for its “Catalys” laser system to be used in two key stages of cataract surgery.
The system, which combines optical coherence tomography (OCT) imaging with a femtosecond laser, is now cleared in the US for capsulotomy – where a circular incision is made in a patient’s lens capsule – and lens fragmentation, where a damaged lens is softened in advance of its removal.
OptiMedica received CE mark approval for the same system earlier this year, meaning that it can now market Catalys across both the US and the European Union.
Company CEO Mark Forchette says that the OptiMedica system is the most sophisticated laser cataract surgery system in the industry, in what is seen as a key growth market for medical lasers – somewhere between 15 million and 20 million cataract surgeries are performed every year and femtosecond lasers are only now beginning to infiltrate the market.
Earlier this month, eye care giant Bausch + Lomb received CE mark approval for its “VICTUS” femtosecond laser system, which performs both cataract and refractive procedures, while US-based LensAR had previously received FDA 510(k) clearance for the capsulotomy stage of the operation.
Where OptiMedica’s laser system is claimed to excel is in the precision of the capsulotomy step. The company says that the size, shape and position of the incision is a key determining factor in the quality of the visual outcome for cataract patients.
“A deviation of just 0.5 mm from the intended effective lens position has been shown to result in 1.00 diopters of refractive error,” it states, adding that Catalys produces capsulotomies within 30 micron of intended size, and 80 micron of intended center, with “near perfect” circularity.
The OptiMedica system also features a “liquid optics interface” that is said to optimize the optical path to a patient’s eye, together with a proprietary guidance system to deliver the ultrashort pulses of laser light.
In a statement prepared by OptiMedica, William Culbertson, MD, from the Bascom Palmer Eye Institute at the University of Miami’s Miller School of Medicine, who led a peer-reviewed study comparing femtosecond cataract surgery with conventional approaches earlier this year, said:
“Catalys is a sophisticated yet simple-to-use device that delivers unequalled precision and is, quite frankly, the most well-designed medical product I have ever seen.” The professor of ophthalmology added: “My colleagues and I have been fortunate to have access to the Catalys for years, and we firmly believe that it will revolutionize cataract surgery.”
Although femtosecond lasers have been used in corneal refractive surgery procedures for many years, there is a major difference with cataracts because the lens sits much deeper within the eye than the cornea, and is more difficult to access. As a result, it is only in the past couple of years that regulatory bodies have begun approving systems for cataract procedures.
But with such approvals now widespread, the market for such systems is set to grow rapidly – particularly in the ageing populations of the western world. The potential for growth prompted Swiss eye care giant Alcon to agree a deal worth up to $750 million last year to acquire LenSx Lasers, the first company to gain FDA clearance for a femtosecond laser system used in cataract surgery. Meanwhile Bausch + Lomb has taken full control of former joint venture Technolas Perfect Vision in a transaction valuing the company at up to €450 million.
OptiMedica remains independent for now, and has been funded by big-name venture capital groups including Kleiner Perkins Caulfield and Byers, and BlackRock Private Equity Partners. The Santa Clara company disclosed a $30.2 million funding round in late 2009, after initially raising $13.8 million in April 2006.
Earlier this month, OptiMedica also revealed that Professor Burkhard Dick, chairman and head of the University Eye Clinic Bochum in Germany, had become the first ophthalmic surgeon in Europe to treat patients with the Catalys system for cataract surgery.