FDA officials chided medical device maker NeoMedix Corp. for violations of U.S. law, saying that the company is selling its Trabectome device without proper agency approval.
NeoMedix won FDA 510(k) approval in April 2006 for the Trabectome device, with indication for "use with compatible electrosurgical instruments in low power microsurgical applications for the removal, destruction and coagulation of tissue. The decision summary doesn’t appear to specify procedures in which the device may be used. The FDA warned that the company’s marketing of the device for use during glaucoma surgery fell outside of the parameters of the 510(k) clearance.
Regulators noted several instances on NeoMedix’s website where the company had touted the Trabectome device in treatment of glaucoma, and the website was still full of such references as of March 12, 2014. The tag-line in the device’s logo reads "micro incisional glaucoma surgery" and the homepage touts the device as a "natural solution for glaucoma treatment."
The Trabectome device uses electrical energy to ablate and remove diseased tissue while providing continuous irrigation and aspiration to remove debris and maintain a safe temperature, according to NeoMedix materials.
The NeoMedix website makes little mention of other procedures or potential treatment pathways for the Trabectome device. The FDA gave NeoMedix 15 days to respond to the inquiry.