Ophtec USA Receives FDA Approval for RingJect Disposable Injector/Delivery System

Source: Ophtec USA

Wednesday, January 11, 2017 | FDA Approval/Clearance , OPHTEC


Ophtec USA recently received FDA approval to commercially sell the RingJect, a disposable injector/delivery system designed for one-time use with capsular tension rings. With the RingJect, a CTR is prepositioned in the injector and is designed to be self-loading for the surgeon’s convenience. The RingJect will be available in two sizes --  the 375 (12/10 mm) and 376 (13/11 mm).

“I use CTRs routinely for my premium IOL patients as I believe this ensures good centration and prevents late movement from capsule contraction. In the rare occurrence that the lens needs to be explanted, it also facilitates surgery as the bag opens up very easily” Professor Sunil Shah said in a company news release. “I prefer Ophtec CTR because they are preloaded, relatively pliable out of injector so they insert without any additional tension on bag and they unhook without manipulation. Hence they add no significant time on for the surgical procedure.”

Ophtec BV has added new technologies in the manufacturing process to develop the RingJect and its product launch. For example, a compression molding technology has been developed allowing the molecular structure of polymethyl-methacrylate (PMMA), which is the material CTRs are composed of, to be redistributed into longer chains resulting in a stronger material.   

Ophtec USA has already begun selling this product to various consumers in the United States. The anticipated demand of this product in the US is expected to increase significantly as surgeons continuously look for ways to improve the efficiency at which they perform ophthalmic surgeries and reduce time in surgery while delivering better patient outcomes.  

 


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