In short
Synergetics USA, Inc., a Missouri medical device company that designs, manufactures and markets innovative microsurgical devices for ophthalmic and neurosurgical applications, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for VersaVIT™, a novel vitrectomy system for the retinal surgery market.
Background
Synergetics USA, Inc. is primarily focused on the surgical disciplines of ophthalmology and neurosurgery. Its product lines focus upon disposable and reusable devices, procedural kits, and the delivery of various energy modalities for the performance of less invasive surgery.
The company’s newly cleared device, VersaVIT is a vitrectomy machine which is claimed to be portable, compact, easy to use and very competitively priced. The system can be run on battery power and gas cartridges and according to the company is ideally suited for ambulatory centres and in-office procedures.
Company comments
“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. “We believe that VersaVIT is a ‘game changer’ given its functionality, portability and competitive pricing relative to traditional vitrectomy systems.”
Regulatory status
The Company is awaiting CE mark approval, which has been submitted and is currently under review.
Source: Synergetics USA, Inc.
