Quantel, AcuFocus receive CE approvals

Clermont-Ferrand, France and Irvine, CA-Ophthalmology technology from Quantel Medical and AcuFocus recently received CE Mark approval.

Quantel received the approval for its Vitra PDT photodynamic therapy laser platform for the treatment of polypoidal choroidal vasculopathy and central serous retinopathy.

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“This comes at an opportune moment, as demand for PDT treatment technologies is expected to increase as the disease’s true prevalence is realized,” said Jean-Marc Gendre, chief executive officer of Quantel. “We’re confident that our world-class laser technology will provide ophthalmologists a quality, cost-effective solution, and are excited to begin commercialization in Europe and Asia.”

Quantel plans to begin commercializing the platform immediately in countries requiring CE registration.

AcuFocus received the approval for its extended depth-of-focus IOL, the IC-8 small-aperture IOL in Europe. The lens is designed to provide exceptional visual quality across a broad range of vision for presbyopic patients with cataracts, according to the company.

The inlay applies the same principles as the company’s inlay (Kamra).

“The Kamra inlay is the ideal solution for presbyopic patients who don’t want or require lens removal, (and) with the addition of the IOL to our patented small-aperture portfolio, we can now provide cataract patients with the same exceptional vision,” said Jim Mazzo, chairman and chief executive officer of AcuFocus.

The company plans to make the IOL available through a controlled release in select markets across Europe. It is not approved for use in the United States.

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