Canadian medical sterilization device company TSO3 said yesterday it won expanded FDA clearance for its Sterizone VP4 sterilizer device, including clearance for sterilizing double and multiple-channel endoscopes.
The expanded approval was based on testing which showed the company’s Sterizone VP4 sterilizer effective when used with both double and multi-channel flexible endoscopes, including ureteroscopes or video colonoscopes, the company said..
“Our extended IFU claims have been cleared by the FDA demonstrating the truly superior capabilities of our Sterizone sterilization system. These extended claims further expand our technology leadership – offering enhanced patient protection in applications where terminal sterilization was not previously possible. With these enhanced claims, we no longer talk about evolutionary claims advancement; rather the Sterizone VP4 Sterilizer is set to revolutionize the medical industry’s standard of care,” CEO R.M. Rumble said in a press release.
TSO3 said the new clearance comes as regulatory authorities seek increased scrutiny in reprocessing medical devices, such as colonoscopes, in lieu of outbreaks of resistant “superbug” bacteria. The company touted the advantages of sterilization over disinfection as it kills off all harmful microorganisms, including bacterial spores.
“We look forward to presenting these enhanced claims in addition to our already industry-leading value proposition to our customers, and will be assessing the need to further expand production capacity in response to customer feedback and demand. I am extremely proud of our team and their unwavering dedication to continue to improve patient care through creating new and meaningful patient infection reduction strategies,” CEO Rumble said in prepared remarks.
The company touted the device as the 1st and only dual-sterilant sterilizer cleared by the FDA for sale in the U.S., the 1st single cycle, low-temperature sterilizer cleared to process a 75-pound load of general instruments and the 1st low temp sterilizer validated for multi-channel endoscopes.
TSO3 said it originally filed for expanded indications for the Sterizone VP4 last December.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.