Spirus Medical announced today that it has obtained marketing approval from the Japanese Ministry of Health, Labor and Welfare for the company's proprietary ENDO-EASE line of endoscopy devices. The Endo-Ease Endoluminal Advancement System features novel "over-tubes" that use a spiral design utilizing simple rotation to facilitate enteroscopy, colonoscopy and ileoscopy.
According to Spirus Medical, the Endo-Ease line is well suited for the Japanese endoscopy marketplace, which emphasizes in-hospital treatment. The Endo-Ease allows both visualization and, if needed, appropriate treatment of gastrointestinal disease. Competing new platforms, such as ingestible "pill cameras", provide only detection, and are administered on an outpatient basis. Endoscopic treatment, under those regimens, needs to be scheduled for a second, in-hospital procedure.
Century Medical, Inc. (CMI), one of Japan's largest independent medical device distributors, has over 150 sales representatives throughout the country to serve one of the largest endoscopic markets in the world. Spirus first announced the partnership in October, 2009. "The approval is an important success for Spirus Medical and CMI's regulatory affairs teams, and will now allow CMI's extensive sales & marketing network to introduce the ground-breaking devices into Japan. We anticipate that the clinical benefits of the Endo-Ease will prove to be highly appealing to health care providers and their patients throughout Japan," said Robert Ailinger, Spirus Medical's Chief Operations Officer.
"We are pleased to be partnering with Spirus Medical, and we look forward to expanding awareness and adoption of the company's innovative technologies," said Akira Hoshino, President & CEO of CMI.
"We foresee a highly productive collaboration with CMI as we work to further extend the applications and value of the Endo-Ease platform technology," said Steven J. Tallarida, President and CEO of Spirus Medical. "With several applications already developed in gastroenterology, and additional ones planned for future markets, we look forward to working with CMI to provide benefits for both the endoscopist and their patients."
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