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22 Dec 2011



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Venture-backed US close gets 510(k) approval for its femtosecond laser / optical adherence tomography aggregate system.



The California-based ophthalmology aggregation OptiMedica has accustomed 510(k) bazaar approval from the US Food and Drug Administration (FDA) for its “Catalys” laser arrangement to be acclimated in two key stages of avalanche surgery.

The system, which combines optical adherence tomography (OCT) imaging with a femtosecond laser, is now austere in the US for capsulotomy – area a annular cavity is fabricated in a patient’s lens abridged – and lens fragmentation, area a damaged lens is ashen in beforehand of its removal.



OptiMedica accustomed CE mark approval for the aforementioned arrangement beforehand this year, acceptation that it can now bazaar Catalys beyond both the US and the European Union.

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Company CEO Mark Forchette says that the OptiMedica arrangement is the best adult laser avalanche anaplasty arrangement in the industry, in what is apparent as a key advance bazaar for medical lasers – about amid 15 million and 20 million avalanche surgeries are performed every year and femtosecond lasers are alone now alpha to admission the market.

Earlier this month, eye affliction behemothic Bausch Lomb accustomed CE mark approval for its “VICTUS” femtosecond laser system, which performs both avalanche and refractive procedures, while US-based LensAR had ahead accustomed FDA 510(k) approval for the capsulotomy date of the operation.

Precision incision Area OptiMedica’s laser arrangement is claimed to excel is in the attention of the capsulotomy step. The aggregation says that the size, appearance and position of the cavity is a key free agency in the affection of the beheld aftereffect for avalanche patients.

“A aberration of aloof 0.5 mm from the advised able lens position has been apparent to aftereffect in 1.00 diopters of refractive error,” it states, abacus that Catalys produces capsulotomies aural 30 micron of advised size, and 80 micron of advised center, with “near perfect” circularity.

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The OptiMedica arrangement additionally appearance a “liquid eyes interface” that is said to optimize the optical aisle to a patient’s eye, calm with a proprietary advice arrangement to bear the ultrashort pulses of laser light.

In a account able 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 abstraction comparing femtosecond avalanche anaplasty with accepted approaches beforehand this year, said:

“Catalys is a adult yet simple-to-use accessory that delivers incomparable attention and is, absolutely frankly, the best well-designed medical artefact I accept anytime seen.” The assistant of ophthalmology added: “My colleagues and I accept been advantageous to accept admission to the Catalys for years, and we durably accept that it will accommodate avalanche surgery.”

Deeper access Although femtosecond lasers accept been acclimated in corneal refractive anaplasty procedures for abounding years, there is a above aberration with amaurosis because the lens sits abundant added aural the eye than the cornea, and is added difficult to access. As a result, it is alone in the accomplished brace of years that authoritative bodies accept amorphous acknowledging systems for avalanche procedures.

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But with such approvals now widespread, the bazaar for such systems is set to abound rapidly – decidedly in the ageing populations of the western world. The abeyant for advance prompted Swiss eye affliction behemothic Alcon to accede a accord account up to $750 million aftermost year to access LenSx Lasers, the aboriginal aggregation to accretion FDA approval for a femtosecond laser arrangement acclimated in avalanche surgery. Meanwhile Bausch Lomb has taken abounding ascendancy of above collective adventure Technolas Perfect Vision in a transaction account the aggregation at up to €450 million.

OptiMedica charcoal absolute for now, and has been adjourned by big-name adventure basic groups including Kleiner Perkins Caulfield and Byers, and BlackRock Private Equity Partners. The Santa Clara aggregation appear a $30.2 million allotment annular in backward 2009, afterwards initially adopting $13.8 million in April 2006.

Earlier this month, OptiMedica additionally appear that Assistant Burkhard Dick, administrator and arch of the University Eye Clinic Bochum in Germany, had become the aboriginal ophthalmic surgeon in Europe to amusement patients with the Catalys arrangement for avalanche surgery.

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