NEWS: Med-Device Startup Gets Clearance For Single-Use Arthroscope
A med-device startup developing high-def, low-cost single-use endoscopes for the arthroscopic surgery market has received clearance from the Food and Drug Administration.
Integrated Endoscopy, with HQ in Irvine, got clearance to market its NUVIS single-use arthroscope.
The company also announced that it has entered into an exclusive arrangement with an Italian company, Frii Medical to market its battery powered, single-use shaver system in the U.S.
The FDA’s action gives U.S. surgeons access to a battery-operated arthroscope that is designed to provide high def visualization via a proprietary optical design, while directly addressing safety and sterility issues associated with traditional, reusable arthroscopes.
The company says the single-use nature of Integrated Endoscopy’s tech provides surgeons with an affordable way to eliminate “bio-burden” and risk of infection and disease transfer due to lapses in instrument reprocessing; eliminates the need for the traditional light source and the associated heat; and can be used on existing video systems in the marketplace.
The global market opportunity exceeds $4B, CEO Brad Sharp said in July 17 press release.
“Since the traditional endoscope was introduced more than 50 years ago, the fundamental design and reprocessing requirements of traditional reusable endoscopes have not changed significantly,” David Bailie, Integrated Endoscopy’s chief medical officer said in the release.
Regarding the battery shave, it delivers the same kind of performance as the traditional corded shaver systems without the cost of the shaver console.
It is provided as a single-use, sterile packaged handle/blade combination with a rechargeable motor/battery.
The company said the benefits of this single-use battery shaver system are similar to the NUVIS single-use arthroscope by eliminating the costs of processing and sterilization, ensuring quality and performance and eliminating the cost of the capital equipment required of a traditional shaver system.
“The synergy between these products makes them a natural fit,” Sharp said.
The company plans to begin marketing them together later this year.