Integrated Endoscopy Receives FDA Approval for nuvis™ Single-Use Rigid Arthroscope

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Superior Optics in Unique Affordable, Single-Use Design Set to Revolutionize U.S. Endoscopy Market

Integrated Endoscopy, Inc., an innovative designer and manufacturer of high-definition, affordable single-use rigid endoscopes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its nuvis™ Single-Use Arthroscope. With this clearance, the nuvis is the only single-use rigid endoscope approved for marketing in the United States.

“We are pleased to have received FDA clearance for the nuvis Arthroscope, which will provide surgeons with first-time quality for every procedure,” said George Wright, president and CEO of Integrated Endoscopy. “The nuvis is the result of years of research, and its patented technology allows us to deliver an affordable single-use rigid endoscope with superior optics that reduces overall procedure costs compared with reusable endoscopes that are expensive to buy and maintain. Patient and staff safety also are enhanced by eliminating the risk of healthcare-associated infections due to inadequately cleaned and sterilized reusable endoscopes, whose designs—and rigorous reprocessing requirements—have not changed significantly since their introduction more than 50 years ago.”

The nuvis Single-Use Arthroscope provides superior optics due to its exclusive integrated optical design featuring 18 molded glass lenses compared with the 32 expensive ground glass lenses used in reusable arthroscopes. These high-quality molded lenses are made with the same technology and innovative low-temperature glass used to mass-produce high-definition, low-cost optics for smart phone cameras. It also features patented, inexpensive, and durable light-emitting diode (LED) technology that provides improved bright-white light at significantly lower temperatures than the fiber optic illumination used in conventional endoscopes.

According to Wright, the nuvis Arthroscope addresses key safety and cost issues associated with reusable endoscopes by eliminating the need for reprocessing between use, scope damage and repair costs, operating room downtime, and inventory logistical issues. Studies show that the total average per-procedure cost of using a reusable rigid arthroscope is more than $172, not including the cost of labor, fiber optic bundles, light bulbs, and other items.

“The low price of the nuvis (less than $200) compares favorably to reusable endoscopes when an accurate and full assessment of total cost of ownership is made,” he said.

 

The nuvis Arthroscope will be available during 3rd quarter 2014, and the company will market the device through a combination of direct sales and distributors.

Endoscopic Surgery Market

According to recent market research reports, approximately 8.3 million arthroscopies were performed in 2013 in the U.S. and Europe. Orthopedic surgery is the fastest growing endoscopic surgery segment, with double-digit annual growth rate anticipated in the U.S. and Europe between 2011 and 2017.

About Integrated Endoscopy

Integrated Endoscopy is a pioneer in the development of high-quality, low-cost single-use rigid endoscopes. The company’s intellectual property portfolio includes 19 issued patents in the United States, Europe, Japan, Australia, and Canada covering the lens system design, LED lighting systems in a rigid endoscope, and high-quality molded glass lenses that are at the core of its cutting-edge devices. This strong patent position makes Integrated Endoscopy uniquely positioned to be the market leader and sole provider of high-quality, low-cost single-use rigid endoscopes. Privately held since its formation in 1996, Integrated Endoscopy’s headquarters and manufacturing are based in Rancho Santa Margarita, Calif.

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