IRVINE, Calif.--(BUSINESS WIRE)--Integrated Endoscopy, a medical device company pioneering the development of high-definition, low-cost single-use endoscopes for the arthroscopic surgery market, today announced it has received clearance from the Food and Drug Administration (FDA) to market its NUVIS® (pronounced “nu-vee”) Single-Use Arthroscope, a first-of-its-kind endoscope designed for use in arthroscopic surgical procedures.
The FDA’s action brings U.S. surgeons access to a unique battery-operated arthroscope that is designed to provide high definition visualization via a proprietary optical design, while directly addressing key safety and sterility issues associated with traditional, reusable arthroscopes. The single-use nature of Integrated Endoscopy’s proprietary technology 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 FDA’s approval of NUVIS not only marks a major step in our company’s development,” said Brad Sharp, Integrated Endoscopy’s CEO. “It also helps bring to the surgical community a technology we believe will be a superior, less expensive and safer new gold-standard in arthroscopic surgery. With the FDA clearance for NUVIS, we can now provide surgeons with an out-of-the-box, battery-operated, single-use endoscope with high-definition image quality at a price point well below that of reusable scopes. Couple that with our patented, low temperature, embedded LED light source, and we believe we can significantly impact a global market opportunity that exceeds $4B. We look forward to making NUVIS the first of many endoscopic innovations we will bring to the surgical community.”
“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,” said David Bailie, MD, Integrated Endoscopy’s Chief Medical Officer. “The NUVIS Arthroscope combines 21st century technologies to create a low-cost, single-use arthroscope with superior high-definition optics. It has the same look and feel as a reusable endoscope while being compatible with existing video systems and attachments. One key benefit from a surgeon’s perspective is the reduction/elimination of cables on the sterile field, such as the light cord. Not only does it reduce the clutter, but it also improves efficiency and safety by eliminating the possibility of cable contamination and associated costs while eliminating the possibility of ‘tip burn’ due to the heat generated by the light source and cord. Ultimately, the NUVIS system eliminates operating room down time and inventory logistics issues associated with reusable arthroscopes, eliminates arthroscope reprocessing procedures completely, and reduces total endoscope costs overall.”
Sharp added that Integrated Endoscopy has also entered into an exclusive arrangement with an Italian company, Frii Medical (www.friimedical.com) to market its battery powered, single-use shaver system in the US. The first of its kind, this battery shaver 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 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 every time and eliminating the cost of the capital equipment required of a traditional shaver system. The synergy between these products makes them a natural fit, and the company plans to begin marketing them together late in 2019.
Integrated Endoscopy’s newly approved battery-operated NUVIS arthroscope will become available to various markets around the world over the coming months, with plans of full availability by early 2020. With over 16 billion arthroscopic procedures worldwide, the NUVIS single-use arthroscope represents a significant opportunity for the company while improving efficiency and safety and reducing costs in operating rooms and surgery centers worldwide.
About Integrated Endoscopy
Irvine, California based Integrated Endoscopy is a pioneer in the development of high-quality, low-cost single-use endoscopes. Its NUVIS® Single-Use Arthroscope technology is revolutionizing the market by delivering high-definition optics in a single-device – providing first-time quality for every procedure. For more information, visit www.iescope.com.