CE Mark for Abbott’s Extended Range of Vision Intraocular Lens for Cataract Patients
Abbott announced today it has received CE Marking (Conformité Européenne) in Europe for the TECNIS Symfony Extended Range of Vision intraocular lens (IOL) for the treatment of cataract patients who may also have a diminished ability to focus on near objects (presbyopia). Standard IOLs can be used in cataract treatment to improve distance vision, but the TECNIS Symfony IOL is a first-of-its kind lens that is intended to provide patients a continuous range of vision including far, intermediate and near distances with reduced incidence of halo and glare comparable to a monofocal lens1. This IOL is not approved for use in the United States.
As the European population continues to age, the number of cataract surgeries is expected to grow faster than the population growth. Patients who suffer from diminished vision from cataracts may turn to surgery at younger ages due to raised expectations of post-surgical outcomes. This may increase patient demand for improved, precise vision and independence from eyeglasses.
In 2013, approximately 3.5 million cataract surgeries were performed in Europe2, making it one of the most common surgical procedures. Abbott is focused on developing products that can provide patients with clear vision at all distances after cataract surgery to help them maintain active, healthy lifestyles.
"With the available advances in IOL technology, many patients are not satisfied with having to wear reading glasses after cataract surgery, which is often the result when using conventional monofocal IOLs," said Gerd U. Auffarth, M.D., professor and chairman, Department of Ophthalmology, Ruprecht-Karls University of Heidelberg, Germany. "The TECNIS Symfony Extended Range of Vision IOL enables physicians to offer patients a continuous range of functional vision for far, intermediate and near distances, with reduced risk of undesired halos or glare."
The TECNIS Symfony extended range of vision IOL is designed to be placed in the lens capsule of the eye to replace the natural crystalline lens that has been removed because of a cataract. It is the first and only presbyopia-correcting extended range of vision IOL designed to provide patients increased independence from eyeglasses and quality vision over a continuous range of distance including far, intermediate and near. This innovative IOL is designed to increase the distance over which an object appears in focus without sacrificing the patient's visual clarity or contrast when compared with standard monofocal IOLs that provide improved distance vision only.
"The TECNIS Symfony Extended Range of Vision IOL represents the latest advancement in cataract technology and expands Abbott's portfolio of the TECNIS family of IOLs," said Murthy Simhambhatla, Ph.D., senior vice president, Medical Optics, Abbott. "This new IOL demonstrates Abbott's consistent innovation in bringing new treatment options to market, enabling physicians to offer their patients clear vision after cataract surgery."
Abbott has commenced a 150-patient study in Europe to evaluate patients' quality of vision at far, intermediate and near distances after being implanted in both eyes with the TECNIS Symfony Extended Range of Vision IOL. The study will also assess both patient and surgeon satisfaction. Preliminary study results are anticipated later this year. Abbott is also conducting a post-market observational study with approximately 400 patients across Europe, including the United Kingdom, France, Germany and Spain, with results expected at the end of 2014.
1 166, Data on File. Extended Range of Vision IOL 3-Month Study Results (NZ).
2 2013 Comprehensive Report on the Global IOL Market, Market Scope, LLC