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The device is under review for the CE Mark.
July 2, 2012
By: Niki Arrowsmith
NULL
Synergetics USA Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for VersaVIT, a vitrectomy system for retinal surgery. A vitrectomy is a procedure by which all the vitreous humor is removed from the eyeball in order to treat a variety of conditions. Synergetics is based in O’Fallon, Mo., and is a manufacturer of microsurgical devices for ophthalmic and neurosurgical applications. “The entry of VersaVIT into the global vitrectomy market is a major milestone in Synergetics’ strategy to enter into higher growth areas of retinal surgery,” said David M. Hable, president and CEO of the company. “We believe that VersaVIT is a ‘game changer’ given its functionality, portability and competitive pricing relative to traditional vitrectomy systems.” The company is awaiting CE Mark approval in Europe, which has been submitted and is currently under review.
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