Cantel Medical (NYSE:CMD) said today it won FDA 510(k) clearance for its Advantage Plus pass-thru automated endoscope reprocessor, making it the first AER available in the US, the company claims.
The newly cleared device is designed for the high-level disinfection of commonly used endoscopes, including duodenoscopes, the Little Falls, N.J.-based company said.
“We strive to deliver real life infection prevention solutions to address the complexities our customers face in setting up successful endoscopy departments. We believe the Advantage Plus pass-thru AER’s availability will transform our customers’ experiences by improving department efficiencies and workflow while maintaining the integrity of the cleaning process and supporting patient safety,” global marketing and biz dev VP Bill Haydon said in a prepared statement.
The Advantage Plus pass-thru AER uses a one-way workflow to reduce human error with a hard-wall separation between dirty and clean reprocessing areas to prevent recontamination of reprocessed endoscopes, Cantel said.
The system is designed to reprocess approximately four to five scopes per hour, and has been cleared for use with Cantel’s Rapicide PA disinfectant.
“The FDA clearance of Advantage Plus pass-thru AER further expands our rapidly growing endoscopy portfolio and delivers on our commitment to safeguard the world from infections through innovative, market leading technologies. As a leader in infection prevention for over 20 years, Cantel is thrilled to announce the availability of this best practice technology in automated endoscope reprocessing to our U.S. customers,” endoscopy division prez Dave Hemink said in a press release.
Last month, Cantel said it acquired Belgium-based healthcare software developer Aexis Medical in a deal worth $24.8 million.
