ARTIFLEX® Receives CE Mark

OPHTEC BV announced today that after several years of clinical testing, the ARTIFLEX® Lens, the latest development in refractive surgery, was awarded the coveted CE approval. Sales throughout Europe will begin immediately. The ARTIFLEX® Lens is for the treatment of nearsightedness and has been long awaited by surgeons and patients who have sought small incision refractive surgery over Lasik and other types of non-reversible eye treatments. The lens is available immediately in Europe to patients whose surgeon has completed a specialized training course. Worldwide introduction will take during the next 12 months as various registrations occur.

The ARTIFLEX® lens is the latest evolution of the ARTISAN® Lens which was designed by world famous Dutch ophthalmologist, surgeon and inventor Prof. Jan Worst, MD. The ARTISAN® Lens concept has been in use since 1978 and has the longest history of use of any surgically implanted / phakic intraocular lens. The significant benefit of the ARTIFLEX® Lens is that it can be inserted through a minimally invasive micro incision, therefore dramatically reducing recovery time and increasing patient satisfaction.

Introduction of the ARTIFLEX® Lens follows years of successful use of it’s parent the ARTISAN® Lens, which currently enjoys the largest market share of any phakic lens world wide. “Although OPHTEC has experienced tremendous success over the years with the original ARTISAN® Lens design, we saw the opportunity for a significant improvement of this unique product, “said Erik Jan Worst, OPHTEC President & CEO. “Surgeons who were involved in the European clinical study were amazed by the clinical results and quick visual recovery. We were impressed with the very high level of interest during the introduction at the European Society of Ophthalmology in Lisbon, Portugal where training courses were standing room only” continued Worst, “With this product, we look forward to maintaining our leadership position in the world wide phakic lens market”.

OPHTEC is a privately held firm with corporate offices in Groningen, The Netherlands. OPHTEC is recognized as the worldwide market leader in phakic lenses. The firm has 145 employees who are responsible for the development, production and sale of a wide range of surgical ophthalmologic products. OPHTEC also owns and operates a privately held ophthalmic and optometric clinic, RCNN, and an ophthalmic surgery center, the Oogheelkundig Medisch Centrum Groningen [Ophthalmologic Medical Centre Groningen], both located in Groningen.


International Investigators in the ARTIFLEX® Multi Centre Study:
Dr. C. Budo, Sint Truiden, Belgium
Dr. H. Termote, Ottignies, Belgium
Dr. E. Hachet, Nancy, France
Prof.Dr. F. Malecaze, Toulouse, France
Prof. Dr. H.B. Dick, Mainz, Germany
Dr. G. Gerten, Köln, Germany
Prof. T. Kohnen, Frankfurt, Germany
Dr. G.P. Georgariou, P. Faliro, Greece
Dr. F. Loureiro, Lisboa, Portugal
Prof.Dr. A.A.P. Marinho, Porto, Portugal
Prof. Dr. M. Izák, Banska Bystrica, Slovakia
Dr. M.A. El-Danasoury, Jeddah, Saudi Arabia
Dr. J.L. Güell, Barcelona, Spain
Prof. J.L. Menezo, Valencia, Spain
Dr. F.J. Potgieter, Pretoria, South Africa
Dr. J.A. Venter, Port Elizabeth, South Africa
Dr.med. R. Spirig, St. Gallen, Switzerland
Drs. B. J. Christiaans, Groningen, The Netherlands
Dr. M. Landesz, Delft, The Netherlands
Drs. M.H.A. Luger, Delft, The Netherlands
Dr. G.P.M. Luyten, Rotterdam, The Netherlands
Drs. R.M.M.A. Nuyts, Maastricht, The Netherlands
Prof.Dr. J.G.F. Worst, Groningen, The Netherlands
Dr. S. Mahjoub, Tunis, Tunesia