Healthcare Industry News: cataract
News Release - May 9, 2007
Medennium, Inc.'s Photochromic IOL, Aurium Obtains CE Mark ApprovalIRVINE, Calif., May 9 (HSMN NewsFeed) -- Medennium, Inc., developer of SmartPlug® and Matrix® intraocular lenses (IOL) announced today that it has obtained CE Mark clearance for marketing its innovative photochromic IOL, Aurium(TM) in Europe. Aurium(TM) is the first and only photochromic IOL ever introduced in the cataract lens industry.
"We at Medennium, Inc. are excited to introduce this innovative lens to cataract surgeons in Europe, and hope that it will satisfy the ever-demanding needs of their patients. Product innovation is the cornerstone of Medennium's philosophy, and the successful introduction of Aurium(TM) underscores this commitment," said Jake Feldman, CEO and President of Medennium, Inc.
"The idea for Aurium(TM) is to provide additional protection for a cataract patient's retina without any compromises, such as night vision," said Stephen Zhou, PhD., Vice President of R&D at Medennium. "The Aurium(TM) is an intelligent lens which responds to a change in the environment," he adds. "For example, it immediately becomes yellow when exposed to sunlight, while in the indoor environment wherein there is no harmful ultraviolet (UV) or blue light present, the lens becomes colorless again, just like a normal IOL."
Blue light ranges from 430 to about 500 nm and is abundant in sunlight. Like UV light, eye exposure to blue light can cause damage to the retina, especially for the ageing population. Moreover, this type of damage can also lead to macular degeneration. To provide additional protection for cataract patients, surgeons are encouraged to use yellow IOLs, which can filter not only the UV light but the harmful blue light as well.
However, because it is well known that vision cells responsible for night vision are most sensitive to blue light, blocking the blue light by a yellow lens may inevitably cause an adverse effect for night vision, a special concern for night driving situations.
"In light of the possibility that yellow IOLs may have an impact on the night vision of patients, ideally we ophthalmologists would like to have an IOL which is yellow in the sunlight and colorless at night. Medennium's Aurium(TM) does exactly that by introducing the photochromic technology into IOLs," said Lillian A. Werner, MD and PhD at John A. Moran Eye Center of University of Utah who conducted the biocompatibility study for Aurium(TM) in a rabbit model in collaboration with Nick Mamalis, MD. Dr. Werner added, "It was amazing to observe that the Aurium lens became yellow color inside rabbit's eyes seconds after it was exposed to UV light and the yellow color disappeared quickly when the UV light was absent."
As part of the CE Mark approval process, clinical data from two clinical sites were used to support the application. "I have implanted 15 patients with Aurium(TM) in one eye and a controlled IOL with yellow color in the opposite eye with 6 months of follow-up time. All of my patients are doing very well. In addition, it appears that Aurium(TM) lenses have a better best-corrected visual acuity in comparison to the control IOLs, especially under weak lighting conditions," said Dr. David Mendez, Director of Instituto De La Vision at Mexicali. Dr. Mendez adds, "I am excited about Aurium(TM) because now my patients have the option to choose an IOL which provides additional protection for their retina, but does not carry the risk for potentially compromising their night vision."
Medennium, Inc. will initially launch Aurium(TM) in selective countries in Europe. By September of 2007, during the European Society of cataract and Refractive meeting in Stockholm, Aurium(TM) will be available to all surgeons in all European countries.
ABOUT MEDENNIUM, INC.
Medennium, Inc. is a world leader in innovative specialty ophthalmic devices. All of its products, including, but not limited to SmartPlug®, Matrix Acrylic®, Aurium(TM), developed and manufactured in Irvine, California with worldwide patent protection, are marketed in more than 40 countries worldwide through the US and international distributor network. For more information, visit the company's website at www.Medennium.com.
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