Quantel Medical's Vitra™ PDT Laser Receives CE Mark Approval
Quantel Medical today announced CE Mark approval for its Vitra™ PDT photodynamic therapy laser platform, for the treatment of polypoidal choroidal vasculopathy (PCV) and central serous retinopathy (CSR). Quantel, the sole manufacturer of this laser technology, plans to begin commercializing the laser platform immediately in countries requiring CE registration.
PCV, a disease of the choroidal vasculature, is present in both men and women of many ethnicities, characterized by detachments of the pigmented epithelium and exudative changes that can commonly lead to subretinal fibrosis. It is reported to be prevalent in 20% to 50% of Asian patients with presumed neovascular age-related macular degeneration (AMD) and in 4% to 12% of Caucasians.1-6 However, it is currently believed that the true prevalence of disease is underreported, and accordingly, additional demand for treatment modalities is anticipated. Studies have demonstrated excellent short-term efficacy of PDT for treating PCV.7-10
CSR, also known as central serous chorioretinopathy (CSC), is an eye disease which causes visual impairment, often temporary, usually in one eye.11-12 When the disorder is active, it is characterized by leakage of fluid under the retina that has a propensity to accumulate under the central macula.
"Quantel is currently the sole provider of a laser approved to treat these two very serious retinal conditions. This comes at an opportune moment, as demand for PDT treatment technologies is expected to increase as the disease's true prevalence is realized. 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. This product development, supported by Novartis, Basel, Switzerland, will propose an updated solution for current and future PDT users."
Jean-Marc Gendre: Chief Executive Officer - Quantel Medical