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Spirus Endo-Ease product line obtains Japanese regulatory approval

Spirus Medical has obtained marketing approval from the Japanese Ministry of Health, Labor and Welfare for the Endo-Ease line of endoscopy devices.

The Endo-Ease endoluminal advancement system features ‘over-tubes’ that use a spiral design utilising simple rotation to facilitate enteroscopy, colonoscopy and ileoscopy.

Spirus Medical said that the Endo-Ease allows both visualization and appropriate treatment of gastrointestinal disease, when compared to ingestible ‘pill cameras’, which provide only detection, and are administered on an outpatient basis.

Reportedly, in October 2009, Spirus has partnered with Century Medical (CMI), one of Japan’s independent medical device distributors, to serve the endoscopic markets in the world.

Spirus Medical chief operations officer Robert Ailinger said that the approval is an important success for Spirus Medical and CMI’s regulatory affairs teams, and will allow CMI’s extensive sales & marketing network to introduce the 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,” Ailinger said.

CMI president and CEO Akira Hoshino said that they are pleased to be partnering with Spirus Medical, and look forward to expand awareness and adoption of the company’s innovative technologies.