World’s first sterile, single-use endoscope coming to market next year

Invendo medical GmbH (Kissing, Germany) announced this week that it has received the CE mark for the invendoscope SC200, the world’s first first sterile, single-use colonoscope. The CE mark will allow the company to sell the device throughout the European Economic Area as well as in other countries that recognize the marking. The invendoscopy E200 system, of which the SC200 is a component, received 510(k) clearance from FDA in September 2016.

“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,” said CEO Timo Hercegfi. “The CE mark is a significant accomplishment for our company, which 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.”

There is heightened public awareness of the potential safety risks involving reusable medical devices since it was revealed last year that a type of medical endoscope was linked to several patient deaths and infections globally because of microbial contamination. The so-called duodenoscope, which is used to treat cancers, gallstones and other digestive conditions, proved to be extremely difficult to thoroughly disinfect following a procedure. This is not an issue with single-use devices. 

As part of the new invendoscopy E200 system, the invendoscope SC200 is a sterile and single-use colonoscope that eliminates the main challenge of gastrointestinal endoscopy: The complex reprocessing of endoscopes and, therefore, patients’ risk of cross-contamination, according to information provided by invendo medical.

Current infection control guidelines require that devices such as colonoscopes only be high-level disinfected, as these devices are not able to sustain the high-temperature heat of sterilization or the long process of gas sterilization over the long term. Though disinfection eliminates most viable microorganisms, it does not remove all of them, creating opportunities for cross-contamination among patients. In fact, says invendo medical, more healthcare-associated infection outbreaks have been linked to contaminated endoscopes than to any other medical device.

Not surprisingly, plastics played a key role in the design and development of this device. When asked for specifics, however, Hercegfi told PlasticsToday that “all relevant aspects of materials used and design solutions are confidential, and we are not able to share details which may be of interest at this point in time.”

In addition to addressing an unmet need in GI endoscopy infection control, the invendoscopy system is robotically-assisted and ergonomically designed to offer gastroenterologists greater control and to enhance physician comfort, said the company.

The company expects to bring the device to market in 2017.