Quantel Medical's Vitra™ PDT Laser Receives CE Mark Approval

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Quantel Medical

12 Sep, 2014, 15:35 GMT

-- Laser Approved for Treatment of PCV, CSR

CLERMONT-FERRAND, France, Sept. 12, 2014 /PRNewswire/ -- 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," commented Jean-Marc Gendre, Chief Executive Officer of Quantel Medical. "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."

About Quantel Medical
Founded in 1993 and headquartered in Clermont-Ferrand, France, Quantel Medical is a global ophthalmic medical device company dedicated to developing leading technologies to improve the treatment of ocular diseases. Quantel Medical has a strong emphasis in research and development, resulting in many first-to-market product introductions and a comprehensive product portfolio of diagnostic ultrasound and surgical lasers for ophthalmologists. These products are available through direct sales operations in the U.S. and France, and through independent distributors in over 80 countries.

Quantel Medical is a division of Quantel (QUA:EN), a world-wide leader in the development of solid-state lasers for scientific and industrial applications. For more information, please visit www.quantel-medical.com.

References
 1.  Yannuzzi LA, Sorenson J, Spaide RF, Lipson B. Idiopathic polypoidal vasculopathy (IPCV). Retina. 1990;10(1):1-8.
 2.  Yannuzzi LA, Ciardella A, Spaide RF, Rabb M, Freund KB, Orlock DA. The expanding clinical spectrum of idiopathic polypoidal choroidal vasculopathy. Arch Ophthalmol. 1997;115(4):478-485.
 3.  Uyama M, Matsubara T, Fukushima I, et al. Idiopathic polypoidal choroidal vasculopathy in Japanese patients. Arch Ophthalmol. 1999;117(8):1035-1042.
 4.  Uyama M, Wada M, Nagai Y, et al. Polypoidal choroidal vasculopathy: natural history. Am J Ophthalmol. 2002;133(5):639-648.
 5.  Laude A, Cackett PD, Vithana EN, et al. Polypoidal choroidal vasculopathy and neovascular age-related macular degeneration: Same or different disease? Prog Retin Eye Res. 2010;29(1):19-29.
 6.  Imamura Y, Engelbert M, Iida T, Freund KB, Yannuzzi LA. Polypoidal choroidal vasculopathy: a review. Surv Ophthalmol. 2010;55(6):501-515.
 7.  Chan WM, Lam DS, Lai TY, et al. Photodynamic therapy with verteporfin for symptomatic polypoidal choroidal vasculopathy: one-year results of a prospective case series. Ophthalmology. 2004;111(8):1576-1584.
 8.  Silva RM, Figueira J, Cachulo ML, Duarte L, Faria de Abreu JR, Cunha-Vaz JG. Polypoidal choroidal vasculopathy and photodynamic therapy with verteporfin. Graefes Arch Clin Exp Ophthalmol. 2005;243(10):973-979.
 9.  Otani A, Sasahara M, Yodoi Y, et al. Indocyanine green angiography: guided photodynamic therapy for polypoidal choroidal vasculopathy. Am J Ophthalmol. 2007;144(1):7-14.
10. Gomi F, Ohji M, Sayanagi K, et al. One-year outcomes of photodynamic therapy in agerelated macular degeneration and polypoidal choroidal vasculopathy in Japanese patients. Ophthalmology. 2008;115(1):141-146.
11. Wang, Maria; Munch, Inger Christine; Hasler, Pascal W.; Prünte, Christian; Larsen, Michael (2008). "Central serous chorioretinopathy". Acta Ophthalmologica 86 (2): 126–45. doi:10.1111/j.1600-12. 0420.2007.00889.x. PMID 17662099.
12. Quillen, DA; Gass, DM; Brod, RD; Gardner, TW; Blankenship, GW; Gottlieb, JL (1996). "Central serous chorioretinopathy in women". Ophthalmology 103 (1): 72–9. doi:10.1016/s0161-6420(96)30730-6. PMID 8628563.