Invendo Medical has received a CE mark for its single-use colonoscope. The device, which secured FDA clearance earlier this year, is the latest iteration of a single-use endoscope technology the company pitches as a way to eliminate the risk of cross-contamination between procedures.
Kissing, Germany-based Invendo’s single-use invendoscope SC200 comes in sterile packaging ready for attachment to a device to control the scope and a video-processing unit. The headline feature is the sterile, single-use nature of the device, which facilitates aseptic setup and eradicates concerns about contamination that have attracted the attention of the FDA and CDC in recent years.
“Our revolutionary technology uniquely addresses the significant challenges associated with the cleaning and disinfecting of traditional reusable endoscopes by providing an ergonomically advanced endoscope that offers both sterility and single use,” Invendo CEO Timo Hercegfi said in a statement. “The CE mark … enables us to provide endoscopists in Europe with a more advanced technology to perform colonoscopies and a system that enhances patient safety over current devices.”
Regulators, device manufacturers and other groups have responded to the contamination risks posed by reusable colonoscopes with cleaning guidelines, automatic washers and design tweaks. But, with these changes failing to eradicate cross-contamination, invendo thinks its product offers the safest option.
Invendo has been pushing the idea for a decade now. Invendoscope SC40, a predecessor to SC200, was CE marked by the time Invendo pulled in $4.8 million in funding in 2008. Another model, SC20, picked up FDA clearance in 2012.
The nods for the latest iteration began in September, when the FDA gave 510(k) clearance to the invendoscopy E200 system and accompanying invendoscope SC200. With the CE mark giving Invendo the green light to market invendoscope SC200 on both sides of the Atlantic, the company plans to start selling the device next year.